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E-Pharmacovigilance Technologies Specialist

Organisational Unit: Corporate Pharmacovigilance

Responsibilities:
•Act as a reference point of contact both at Corporate and Affiliate for the introduction, validation and maintenance of tools used in PV (e.g. safety database, front-end solutions, robotic process automation, business intelligence tools)
•Act as a reference point of contact for the IT Service Providers
•Act as Eudra Vigilance (EV) trusted Deputy
•Management of the most important safety information dictionaries (e.g. MedDRA, WHO)
•Represent GPV on the basis of the knowledge of the business processes and procedures
•Supervise local reporting rules for further validation and corresponding updates to the systems
•Evaluate the compliance of service with respect to requirements
•Support in the data extraction of data for the management of compliances and pharmacovigilance system master file maintenance

Activities:
•Assess technology requirements and new needs to prioritize them and conceive evolutionary strategies for the service, in collaboration with Global Information and Communications Technology (GICT) business partner
•Plan the implementation of IT solutions in the pharmacovigilance department
•Manage corporate portals and gateways for cases’ e-submissions, (e.g. rejections and system reporting rules)
•Evaluate the compliance of service with respect to requirements
•Assist PV Users (first point of contact) and PV Service Providers in the ordinary use of the service, evaluate skills and organize the necessary training activities in collaboration with the line manager
•Develop and maintain Standard Operating Procedures and Working Instructions in the field and administer concerned training
•Upload PV documents and procedures in the Electronic Documentation Management System (EDMS) through the appropriate workflows
•Participate in audit and inspection activities

Education: Degree in pharmaceutical chemistry, biological sciences or biomedical engineering, informatics

Experience: At least 1 year of experience as Technology Leader or in Pharmacovigilance

Technical skills:
•Remain self-educated and up to date in all IT systems developments to ensure related implementation
•Understanding and management of the most important safety information databases
•Excellent analytical, technical and IT capabilities

Soft Skills:
•Effective communication and interpersonal skills, with proven ability to work in teams
•Ability to organize and prioritize tasks both individually and across team to achieve established deadlines while maintaining high-quality performances

Languages: Good English
Type of contract: Maternity cover
Place of work: Parma, Italy

 

Degrees of interest: Degree in pharmaceutical chemistry, biological sciences or biomedical engineering, informatics