23 september | h. 9 pm
WHAT IS BIO PHARMA DAY?
Bio Pharma Day is an exclusive career event organized by Jobadvisor, entirely dedicated to job and training opportunities in the pharma and biotech industries.
Bio Pharma Day is aimed at students, graduates, and young professionals with backgrounds in biomedical sciences, biotechnology, chemistry, pharmacy, medicine and healthcare, and medical and biomedical engineering, from leading Italian universities.
In 2024, Bio Pharma Day will consist of two virtual fairs (in March and October) followed by two on-site events (in Milan and Rome).
Are you a Company willing to attend?
For more information or a quotation, please contact us:
T: + 39 393 92.55.808
E: biopharmaday@jobadvisor.it
WEBINAR
You can attend the live streaming session or watch the video recordings.
OPPORTUNITIES
Here you will find the list of opportunities at Bio Pharma Day.
More Opportunities will be added soon!
If you are logged in, the first ones marked with or are close to your degree or field of studies.
Application will be open from 16th October until the end of the Virtual Job Fair!
Researcher in ex vivo dietary microbiome interventions
Employer: Copenhagen University
Place of employment
Novo Nordisk Foundation Center for Basic Metabolic Research (CBMR) is an academic research Center that pioneers groundbreaking research towards better cardiometabolic health. Through collaborative interdisciplinary research from single-cell genomics to whole-body systems, CBMR aims to transform the basic understanding of cardiometabolic health and accelerate its translation into prevention and treatment strategies. The Center’s uniquely multi- and interdisciplinary approach combines research in genetics, physiology and pharmacology, to better understand the complex interplay of the many factors that drive cardiometabolic disease.
The Role, Project & Departement
We are looking for an experienced and motivated Researcher having extensive experience with ex vivo and in vitro microbiome culture and characterization to work in the Arumugam Group at The Novo Nordisk Foundation Center for Basic Metabolic Research (CBMR). The position is a 2-year position starting December 1, 2024, or after agreement.
The project aims to decipher how dietary components affect specific members of the human gut microbiome using high-throughput dietary interventions on ex-vivo human gut microbiomes.
The Microbiome Systems Biology research group led by Associate Professor Manimozhiyan Arumugam investigates how health and diseases are influenced by our gut microbiome, how the gut microbiome interacts with the host and environmental factors, and how we can therapeutically modulate the gut microbiome to improve metabolic health. The group takes an interdisciplinary approach combining multi-omics microbiome data to study host-microbial cross-talk.
Responsabilities
Your tasks will include:
- In-vitro culturing and characterizing complex microbial communities; designing and performing dietary/nutrient intervention on these communities; and performing molecular microbiology characterizations.
- You will work closely together with lab technicians, bioinformaticians and researchers at multiple levels.
- We expect you to operate and run fed-batch anaerobic fermenters, perform sample collections and extraction of nucleic acids and metabolites.
- You will be responsible for coordinating the running of multi-omics (metagenomics, metatranscriptomics, meta-proteomics and metabolomics) and data analysis with technicians and bionformaticians.
- You will also participate in collaborative projects with other research groups at the Center that involves in vitro culturing of gut microbiota.
- Lastly, you will be expected to actively contribute to creating novel ideas, writing research publications and grant applications, supervising students, and presenting the results at seminars and conferences.
Requirements
We are looking for a highly motivated and enthusiastic Researcher with the following competencies and qualifications:
Essential criteria:
- PhD in microbiology, molecular biology or a similar field
- Minimum of three years’ of postdoc experience.
- Strong project management and coordination skills.
- Solid experience in operating large volume anaerobic chambers.
- Solid experience in operating fed-batch fermenters (e.g. SHIME, TIM-2) and maintaining continuous cultures of fecal microbial communities.
- Strong experience in generating and interpreting metabolomic data from in vitro microbial communities.
- Strong collaborative skills; ability to share knowledge and expertise, and provide support to a multidisciplinary team.
- Proven track record showing scientific productivity in peer reviewed journals.
- Excellent written and oral communication skills in English.
- Strong interest in learning more about the life science area, particularly metabolic disorders.
Desirable criteria:
- Experience in culturomics approaches.
- Experience in setting up defined synthetic microbial communities in vitro.
- Experience in identifying high-value compounds from microbial world.
- Insight in the area of health, life science and nutrition research.
Terms of employment
The employment as Researcher is a full time and fixed-term position for 2 years. Starting date is December 1, 2024, or after agreement.
Salary, pension and terms of employment will be in accordance with the agreement between the Ministry of Taxation and AC (Danish Confederation of Professional Associations). Depending on qualifications, a supplement may be negotiated.
Non-Danish and Danish applicants may be eligible for tax reductions, if they hold a PhD degree and have not lived in Denmark the last 10 years.
The position is covered by the “Memorandum on Job Structure for Academic Staff at the Universities” of June 28, 2013.
Further information
For further information please contact Associate Professor Mani Arumugam at arumugam@sund.ku.dk. For questions regarding the recruitment procedure, please contact SUND HR CBMR at SUND-HR-CBMR@sund.ku.dk
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PhD Scholarships in Piezoelectric Biopolymer Technology and Devices for Drug Delivery on Demand – DTU Health Tech
Employer: Technical University of Denmark
If you are establishing your career as a scientist and you have the ambition to develop groundbreaking smart technologies and devices for healthcare, this is the right research project for you.
The aim of the PhD project is to explore and develop new piezoelectric biomaterials and technologies for controlled drug release in smart devices by the application of ultrasound. The focus of the activity will be i) to produce thin films of biomaterials with high piezoelectric properties and loaded with drug molecules, ii) to develop MEMS devices based on piezopolymers, and iii) to develop and optimize a strategy for the remote release of drugs on demand. Within the framework of IDUN, we have extensively explored engineered micro-encapsulated pharmaceutical compounds and more advanced oral drug delivery concepts. In addition, we have expertise on developing piezoelectric materials and device fabrication methods for sensors and actuators for the human body. The PhD candidate will be a part of the IDUN center of excellence, led by Prof. Anja Boisen at DTU Department of Health Technology, and will work under the supervision of Prof. Massimo De Vittorio. IDUN is a highly cross-disciplinary research center with over 40 members, that focuses on development of micro and nanotechnology-based sensors, detection systems and drug delivery devices.
Responsibilities
Your overall focus will be on the design, realization, and test of devices such as smart pills or flexible MEMS transducers based on piezoelectric biopolymers such as chitosan and cellulose, the two most abundant biopolymers on earth. You will work with nearby colleagues and with academic, clinical, and industrial partners in Denmark as well as abroad.
Your primary tasks will be to:
- Develop biopolymers thin films embedding drugs with high piezoelectric properties.
- Tailoring the optical, mechanical, piezoelectric and electrical properties of the thin films by advanced and innovative fabrication methods for improving retention and drug delivery on demand.
- Design and fabricate piezoelectric devices by advanced micro and nanofabrication methods.
- Employ ultrasound in order to trigger and speed up the drug release from the piezoelectric biopolymers. Tests will be executed first in vitro and then, after successful validation, in vivo.
- Teach and supervise BSc and MSc student projects, and be co-supervisor for PhD students
The research activity will be carried out within the framework of the Center of Excellence – IDUN. In IDUN, our motto is ‘bringing science to life’ and we believe in openness, inclusiveness, having ambitions, making a difference and collaboration.
You will play a role mainly in the “Optomechanical Biointerfaces” research group coordinated by prof. Massimo De Vittorio of the IDUN section, and you will interact with several members of IDUN working in different disciplines, such as biology, microfabrication, pharmaceutical science and polymer science. The project is highly interdisciplinary, and we expect that you enjoy teamwork.
Requirements
- You have a background in materials science, chemistry and/or microfabrication technologies.
- You are highly independent, self-motivated and enjoy collaboration in a multidisciplinary academic environment.
- You have the ability to drive the project forward, supervise students and achieve ambitious goals.
- You must have a two-year master's degree (120 ECTS points) or a similar degree with an academic level equivalent to a two-year master's degree.
We offer
DTU is a leading technical university globally recognized for the excellence of its research, education, innovation and scientific advice. We offer a rewarding and challenging job in an international environment. We strive for academic excellence in an environment characterized by collegial respect and academic freedom tempered by responsibility.
Terms of employment
The appointment will be based on the collective agreement with the Danish Confederation of Professional Associations. The allowance will be agreed upon with the relevant union.
The period of employment is 3 years. The expected start date is 1 January 2025 or shortly thereafter.
Further information
Further information may be obtained from Professor Massimo De Vittorio, mdevit@dtu.dk
Technicians / Service Engineers – DTU Nanolab
Employer: Technical University of Denmark
At DTU Nanolab, we are expanding our activities within micro- and nanofabrication and therefore need more technicians/service engineers to join us in the development of the technical solutions of tomorrow. DTU Nanolab is one of the world’s best-equipped open access centers within nanofabrication and characterization located at the Technical University of Denmark in Copenhagen. We are seeking curious and dedicated candidates to join our technical support teams in up to four new positions. We encourage both experienced technicians as well as newly educated candidates with a background from vacuum, refrigeration or mechatronics systems to apply.
Our cleanroom facility houses more than 150 highly advanced tools. The tools combine many different areas such as high vacuum technology, RF plasma, gas-handling systems (toxic and non-toxic), pneumatic control systems, and heating/refrigeration systems. This means that you should be able to navigate and troubleshoot in systems with high complexity.
Responsabilities
You will become a member of one of our equipment groups that consist of process specialists and equipment engineers. Here, you will be working together with extremely competent specialized colleagues with a focus on repair and maintenance to ensure that the equipment can meet our quality standards. We expect you to strive to deliver high quality, safe and reliable solutions.
Key tasks include:
- Take part in the equipment maintenance
- Troubleshooting/repair of equipment breakdowns
- Participate in organizing maintenance and repair tasks
- Keep focus on safe working environment
- Maintaining spare parts inventory
- Carrying out machine upgrades
- Documenting breakdowns, repairs and maintenance tasks
Requirements
For these positions, you should have:
- A minimum of 3 years relevant education within automation, mechatronics or electronics or related technical field relevant work experience may compensate for lack of formal education.
- Experience of working with vacuum systems, pneumatic controls, electronics, and gas systems would definitely be of benefit but not essential as we are prepared to train the successful candidates.
- You should be safety minded, self-driven, and pro-active. Since you will be working as part of a team, it is important to have a positive and open-minded attitude.
What we offer
We offer an interesting and challenging job in an international atmosphere with the focus on research, teaching, innovation, and scientific advice for the benefit of the surrounding community. We have an informal and welcoming work atmosphere where commitment is essential, and we keep up a good spirit. Our approach to planning and conducting tasks is team oriented with focus on a well develop social work environment. We offer great flexibility in the position and expect similar flexibility from you.
Terms of employment
Salary and appointment terms are in accordance with either the collective agreement with the Danish Confederation of Professional Associations (AC), or the OAO-S Joint Agreement and the organization agreement for Laboratory Technicians and IT staff (HK/Stat), for Craftsmen and Technicians, for Engineering Assistants and Research Technicians at research institutions, etc., or other relevant agreement.
The position is permanent and full-time (37 hours per week). Starting date as soon as possible (according to mutual agreement).
The workplace is DTU Lyngby Campus.
Further information
If you would like additional information about the position, please contact Head of Process Engineering Flemming Jensen, flje@dtu.dk
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Laboratory Manager for reNEW
Employer: Copenhagen University
Place of employment
The Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW is a worldwide consortium with nodes at the University of Copenhagen, Murdoch Children’s Research Institute, Melbourne, Australia and Leiden University Medical Centre, Netherlands. Researchers within reNEW addresses fundamental questions in stem cell biology and translate research findings to products that will help patients with incurable disorders such as congenital kidney disorders, diabetes, heart defects, neurological conditions, chronic ulcerative conditions, respiratory diseases, bladder defects and infertility.
reNEW Copenhagen is a vibrant, internationally diverse, and ambitious research center with state-of-the-art facilities located at the Faculty of Health and Medical Sciences, University of Copenhagen. The setting is ideally suited for seamless collaboration and access to a large variety of technology platforms within the Copenhagen area as well as within the other reNEW units in Melbourne and Leiden.
The Role
The role of the laboratory manager is to support and enable researchers to perform their work safely and efficiently while ensuring smooth operations within the reNEW laboratories.
The laboratory manager will report directly to the center management and head of staff.
Responsabilities
The tasks include:
- Ensuring optimal usage of instruments and laboratories.
- Ensuring that the laboratories are following all legal requirements.
- Communication and training of health and safety rules.
- Arranging procurement and services of common equipment.
- Supporting purchase of common laboratory items, including through contact with suppliers, and general organization of stocks, shipment reception and distribution within reNEW.
- Managing the lab operations team, including task and work assignment
- Collaboration and communication with the laboratory users.
- Collaborate and coordinate with reNEW Technology Platform leads to ensure continuous and smooth daily operations.
- Organisation of laboratory users group meetings.
- Taking part in various meeting within the university (Chemical coordinator, lab manager, etc.).
- Budgeting and reporting of common laboratory expenses and handling of internal cost recovery where applicable.
- Reacting to matters raised by laboratory colleagues and providing guidance and support to address suggestions and incidents.
Requirements
- You have as a minimum a laboratory or university-based education within the field of life sciences, natural sciences or similar.
- You have experience in laboratory management (minimum of two to three years) and people management.
- You have experience in GMO1 laboratory settings, including tissues culture.
- Experience in Kemibrug, GMO2 laboratory, Sharepoint, booking systems, and/or Lab Guru is desirable.
- Experience and training in health and safety rules and regulations is desirable.
- Very good communication skills in Danish and English (written and verbally).
- You are a friendly and open, yet firm and effective communicator across the broad spectrum of scientific employees within an internationally staffed institution.
- You have an efficient and self-organised working style and experience of how to effectively communicate in a multifaceted organisation and smaller task-oriented teams.
- You commit to being physically present and readily available in the lab during working hours.
We offer
- A stimulating, challenging and multifaceted research environment
- A combination of active scientific service platforms to interact with, and to develop ideas together to improve our lab for everyone
- Involvement in cutting-edge research in a diverse and multicultural community
- Possibility for continued education and training
- Attractive employment conditions
- Centrally located workplace.
Terms of employment
Your employment will be at Novo Nordisk Foundation Center for Stem Cell Medicine, University of Copenhagen. The position is full-time (37 hours per week) and for 2 years, and it is open for appointment on 15th of November 2024 or as soon as possible.
Employment as Biomedical Laboratory Scientist will be in accordance with the agreement between the Danish Ministry of Finance and Danske Bioanalytikere
Employment as laboratory technician will be in accordance with the agreement between the Danish Ministry of Finance and OAO/HK STAT. The position is placed in salary group 5.
Depending on qualifications a supplement may be negotiated.
Further information
For further information please contact Associate Professor, Mariaceleste Aragona; mariaceleste.aragona@sund.ku.dk
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Two Laboratory Assistant positions in the Wennerberg Group
Employer: Copenhagen University
Place of employment
The Wennerberg Group at the Biotech and Research Innovation Center (BRIC), University of Copenhagen, is looking for two Laboratory Assistants for laboratory maintenance with effect from November 15, 2024.
The Wennerberg group at BRIC focuses on identifying new effective precision cancer therapies. This is done with a systems-driven approach where we combine chemical biology, phenotypic profiling, molecular profiling, and informatics to gain an understanding of individual cancers, their drug resistance mechanisms, and how they may be targeted. Our goal is to build the foundation for new types of stratified and individualized curative treatment strategies for cancer patients.
We offer creative and stimulating working conditions in dynamic and international research environment. Our research facilities include modern laboratories, and several core facilities shared between the 24 research groups at BRIC and the neighbouring Finsen Laboratory.
Responsabilities
We are looking for two part-time employees who want to help us with our routine laboratory duties. The jobs entail maintaining our laboratory supplies together with fulfilling weekly cleaning duties. More specifically, your tasks will include:
- Revising our stocks of general laboratory supplies (i.e., culture plates, pipette tips, PBS, etc.).
- Filling in order forms for the products that are low in stock.
- Perform weekly cleaning of our cell lab including incubators, water baths, and LAF benches according to our cleaning guidelines.
Working hours are expected to be divided over 3-4 days/week for a total of 12 h/week.
Requirements
We are looking for a highly motivated and enthusiastic individual to help us out as a laboratory assistant.
- We expect that you have an ongoing bachelor’s and/or master’s biology education.
- We also expect that the successful candidate is systematic, detail-oriented, and self-driven.
- Previous laboratory and research work experience, as part of courses, internships, or employment is a plus.
Terms of employment
Starting date is as soon as possible, with November 15, 2024, being the desired start date. The employment as Laboratory Assistant is a fixed term and part-time position with an average of 12 working hours per week until January 31, 2026.
The employment is made in accordance with the Collective Agreement between the Danish Ministry of Finance and the Organisations of Public Employees – governmental institutions (the OAO-S collective agreement) and the Professional Agreement for clerical employees, laboratory technicians and IT officers in the state.
Further information
For further information please contact Krister Wennerberg, krister.wennerberg@bric.ku.dk
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Staff Scientist in Molecular Palynology at GLOBE Institute
Employer: Faculty of Health and Medical Sciences University of Copenhagen
Place of employment
The place of work is at the Section for GeoGenetics, Globe Institute, University of Copenhagen. We offer supportive, creative, and stimulating working conditions within a dynamic and international research environment. Our research facilities include a LEAF GOLD certified molecular lab, designed for generating genomic-scale datasets from both modern and ancient specimens, complemented by high-capacity computational servers adept at handling such data.
The Role & Depertement
We invite applications for the position of Staff Scientist in Molecular Palynology. This role is a fixed-term position limited to a period of four years, commencing on 1 January 2025 or as soon as possible thereafter. The position will be based at the Globe Institute, University of Copenhagen.
The successful candidate will join the Conservation Palaeogenetics & Palaeoecology Group at the Section for GeoGenetics, led by Assistant Professor Ana Prohaska. We work at the interface of palaeoecology, ancient genetics, evolutionary biology, and conservation science to understand how species and ecosystems responded to past environmental change and how this understanding can inform conservation decision-making today. Our focus is on identifying and, where possible, recovering genetic diversity relevant to preserving Earth’s contemporary biodiversity into the future. For more information about the group and our research, please see: globe.ku.dk/research/geogenetics/prohaska-group.
Your work will be embedded within the newly awarded Ancient Environmental Genomics Initiative for Sustainability (AEGIS) funded by the Novo Nordisk Foundation. This interdisciplinary research initiative aims to build a more sustainable and secure food production system while also preserving biodiversity in cropping systems under climate change. Its approach is to produce new knowledge and develop innovative methodologies in ancient environmental DNA to identify important organismal associations and genetic adaptations relevant to future food security. The initiative brings together a large international network of researchers with expertise in genetics, ecology, evolutionary biology, plant sciences, computer science, statistics, geology, archaeology, and more.
Responsabilities
The successful candidate will join an exciting new research programme within the AEGIS aimed at advancing the recovery and analysis of ancient pollen DNA using state-of-the-art single-cell sequencing technologies. The main objective of this programme is to develop and employ high-throughput methods for reconstructing ancient plant genomes, which will be applicable to a wide range of plant species worldwide. The selected candidate will contribute to and support (1) the wet lab workflow for sequencing bulk and single pollen DNA in a clean lab setting, and (2) its application to fossil pollen records from various depositional settings, as part of AEGIS’s Data Engine.
The tasks include but are not limited to:
- Responsibility for the daily operation of the instrumentation for pollen isolation and handling.
- Responsibility for preparing pollen samples for extraction and library preparation and coordinating their submission to other laboratory pipelines.
- Participation in the development and implementation of protocols for fossil pollen DNA extraction, library preparation and sequencing.
- Participation in the establishment of the bioinformatic pipeline for the analysis of ancient pollen DNA data.
- Technical support in planning and troubleshooting.
- Participation in the scientific activities of the group and the initiative.
- Keeping up to date with technological developments.
- Work in close collaboration with other scientific staff and academics at the section.
Requirements
We are looking for a highly motivated and energetic candidate with the following competencies and experience:
Essential qualifications and skills
- MSc degree in molecular biology, (paleo)ecology, genetics, evolutionary biology, or a related field.
- Extensive experience in palynological analysis.
- Demonstrated experience in molecular biology methods.
- A genuine interest in developing and advancing wet lab methodologies and protocols.
- Self-motivation, pragmatic mindset, strong work ethics, and good interpersonal skills.
- Ability to organise time and work effectively and responsibly, independently and in teams.
- Strong attention to detail with demonstrated skills in troubleshooting.
- Enthusiasm to be part of an interdisciplinary research project and work collaboratively with scientists across a wide range of disciplines.
- Fluency in both written and spoken English (due to the institute's international profile).
Desirable experience and skills
- PhD in molecular biology, (paleo)ecology, genetics, evolutionary biology, or a related field
- Knowledge of ancient DNA laboratory techniques.
- Knowledge of single-cell laboratory techniques.
- Experience with the production of single-cell and/ or ancient genetic data.
- Experience with statistical data analysis.
Terms of employment
The average weekly working hours are 37 hours per week.
The position is a fixed-term position limited to a period of four years. The starting date is 1 January 2025 or as soon as possible thereafter.
Employment will be in accordance with the provisions of the collective agreement between the Danish Ministry of Taxation and AC (the Danish Confederation of Professional Associations) as Academic Research Staff.
The monthly salary will be based on the number of years of work experience (seniority) with the possibility to negotiate a salary supplement based on prior experiences and qualifications. The employer will pay an additional 17.1 % to your pension fund.
Further information
For further information regarding the position, please contact Ana Prohaska; anaprohaska@sund.ku.dk
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Corsi di formazione per scegliere la Carriera giusta per te
Formazionenelfarmaceutico.com è la prima piattaforma e-learning nata in Italia, per fornire a laureandi, neolaureati, giovani professionisti e professionisti del settore che vogliono studiare, aggiornarsi ed essere al passo con le novità del mondo della ricerca clinica.
La piattaforma conta ad oggi più di 15.000 iscritti, oltre 250 corsi ed innumerevoli trainer con una formazione completa al tuo servizio.
Il panorama del mondo Pharma è in continua evoluzione, ed è sempre pronto a fornire nuovi spunti di crescita professionale. A partire da questo articolo potrai scegliere il ruolo giusto per te, troverai elencate diverse figure, le loro competenze e i loro percorsi formativi.
Chi è il Clinical Research Associate?
Generalmente chiamato CRA, o Clinical Monitor, è colui che si occupa della valutazione, dell’andamento e del monitoraggio dello studio presso i centri clinici, per garantire che la ricerca venga effettuata in ottemperanza al protocollo, alle Procedure Operative Standard, alle disposizioni normative vigenti e alle Good Clinical Practice (GCP).
Suo compito è quindi selezionare i centri clinici, sottomettere la documentazione al Comitato Etico e alle autorità competenti, svolgere i training iniziali agli sperimentatori e gestire le visite di monitoraggio al centro.
Per poter svolgere il proprio ruolo, il futuro CRA dovrà essere in possesso di una laurea magistrale in materie scientifiche, avere una buona conoscenza delle GCP e della metodologia della ricerca clinica con almeno 40 ore di formazione teorica, effettuare almeno 20 giorni in affiancamento con un CRA esperto per capire al meglio come funziona il monitoraggio degli studi presso i centri sperimentali. Sono richieste competenze organizzative e di gestione delle attività, ottime capacità comunicative in lingua italiana e inglese.
Questo ruolo prevede la possibilità di viaggiare per buona parte del tempo, ma anche di svolgere parte della propria attività direttamente in sede, o dalla propria casa.
Chi è il Clinical Research Coordinator?
Questa figura è anche conosciuta come study coordinator o in abbreviazione come CRC. È il coordinatore della sperimentazione clinica. Funge da punto di raccordo tra tutti i professionisti del team di ricerca, tra cui Principal Investigator (PI), Comitato Etico, Sponsor, Farmacia Ospedaliera ecc. Supporta il PI nella conduzione dello studio clinico, assicura la qualità del dato proveniente dalle sperimentazioni cliniche e gestisce in loco le visite di monitoraggio da parte degli sponsor.
Questo ruolo viene svolto all’interno delle aziende ospedaliere o degli IRCCS. È richiesta una laurea in materie scientifiche, conoscenze in ambito GCP, capacità organizzative e di time management. Inoltre, ha buone capacità comunicative.
Il suo lavoro si svolge in buona parte in presenza.
Entriamo nel mondo della qualità. Chi è l’Auditor?
È il professionista che in accordo al D.M. del 15/11/2011 può condurre audit. Gli audit sono valutazioni indipendenti volte ad analizzare con attenzione tutto ciò che concerne uno studio clinico, dalla documentazione, alle strutture, ai laboratori interessati. Per poter svolgere questo ruolo è necessario il possesso della laurea specialistica in materie scientifiche, almeno 60 ore di formazione teorica, almeno 20 giorni di auditing in affiancamento ad un auditor esperto e almeno 4 mesi di attività negli ambiti di quality assurance e quality control.
E’ richiesta attenzione ai dettagli, ottime capacità relazionali e analitiche e il saper lavorare in team.
Il lavoro sarà svolto nella maggior parte del tempo da remoto, fatta eccezione per le trasferte necessarie per l’esecuzione di audit da svolgere presso il centro selezionato.
Chi è il Quality Assurance (QA)?
È il responsabile del sistema di gestione della qualità della ricerca clinica, che garantisce la conformità delle attività aziendali e degli studi clinici in accordo alle normative vigenti. Assicura che il sistema di qualità della ricerca clinica sia efficace affinchè l'integrità e l'affidabilità dei dati, e la salute e il benessere dei soggetti partecipanti siano tutelati. Si occupa di controllare, redigere e modificare le SOP, gestendo le non conformità e monitorando le Azioni Correttive e le Azioni Preventive (in inglese, CAPA).
Ma come si diventa QA?
È richiesta una laurea specialistica non necessariamente in materie scientifiche, almeno un anno di attività pratica documentata in materia e almeno 15 giorni di formazione teorica nel settore della qualità. Il profilo ideale è diplomatico, ha ottime capacità di comunicazione, di coordinamento delle attività ed è flessibile.
Il quality assurance svolge il proprio ruolo in ufficio.
Chi è lo Start Up Specialist?
È colui che è responsabile del coordinamento delle attività che riguardano la sottomissione di uno studio clinico, in accordo con le GCP, le SOP e le normative vigenti. Si relaziona con il team della Contract Research Organization, con l’azienda ospedaliera e con lo Sponsor. Si occupa di eseguire gli studi di fattibilità, selezionare i centri, preparare la documentazione necessaria per lo studio clinico. La sua preparazione iniziale, in quanto figura entry level, è molto basica. Non è richiesta la laurea in materie scientifiche, si richiede una buona
conoscenza della lingua inglese e buone abilità informatiche. Inoltre, è richiesta una buona capacità di saper lavorare in gruppo, attenzione ai dettagli e di time management.
Spesso questo specialista è definito in house, poichè svolge il suo lavoro direttamente in ufficio.
Chi è il Medical Science Liaison (MSL)?
È il consulente altamente qualificato del mondo aziendale farmaceutico. Se si ha già esperienza nel mondo farmaceutico o nel mondo della ricerca clinica, si potrebbe rivestire questo ruolo. Diventando il punto di riferimento delle figure mediche, si avranno contatti con i KPI (Key Opinion Leaders), i clinici e gli sperimentatori, intercettando le loro esigenze, ma allo stesso tempo comunicando le novità e le caratteristiche dei prodotti farmaceutici dell’azienda per cui si lavora. Comprendendo il mercato farmaceutico e le loro dinamiche, si sapranno cogliere le nuove opportunità di sviluppo scientifico e presentarle all’azienda. Si diventerà cultori della materia, partecipando a numerosi congressi e pubblicando articoli scientifici sulle più importanti riviste mediche.
Ma come si diventa MSL?
Ad una buona determinazione, si affianca un solido background scientifico, una pregressa esperienza nella ricerca scientifica (meglio se clinica) e conoscenza del sistema sanitario del Paese per cui si lavora. In questo caso, circa il 25-75% del proprio tempo lavorativo, l’MSL lo trascorre viaggiando.
Chi è il Pharmacovigilance Specialist in area pre-marketing?
È la figura aziendale che si occupa di farmacovigilanza, disciplina volta alla sorveglianza e alla gestione degli eventi avversi dei farmaci. Il suo è un ruolo chiave nell'interazione con altre figure professionali come medici e staff del centro sperimentale, Sponsor e autorità regolatorie. Il Pharmacovigilance Specialist, infatti, monitora i dati di safety provenienti dagli studi clinici, comunicando le reazioni gravi alle autorità regolatorie e contribuendo alla valutazione del rapporto rischio/beneficio dei farmaci sperimentali.
Ma come si diventa Pharmacovigilance Specialist?
È consigliato possedere un solido background in farmacologia, conoscere la normativa vigente e/o avere esperienza pregressa nell’ambito, avere buone capacità di analisi e di redazione di report. Il lavoro può essere svolto in modalità remota o ibrida ed è fondamentale la conoscenza della lingua inglese.
Il punto che accomuna tutti i ruoli della ricerca clinica, è la formazione. Conoscere le GCP, le normative e tutto quello che ruota attorno a questo mondo è fondamentale per iniziare e fare la differenza.
Il dipartimento di training service di ClinOpsHub si occupa proprio di questo, partendo da corsi come Missione CRA che forniscono una preparazione da entry level al Missione QA, Missione MSL e molto altro ancora per specializzarsi.
Per saperne di più partecipa al webinar del 17 ottobre: Il ruolo del CRA nella Contract Research Organization
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Per maggiori informazioni: www.FormazioneNelFarmaceutico.com
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