Pharmacovigilance Intern

The intern, under the supervision of Global Pharmacovigilance Operation Department Manager, will be involved in all the activities related to the Pharmavogilance agreement management. He/She/They will have the opportunity to interact with many internal and external stakeholders like Quality Assurance R&D, Legal and Corporate Affairs, International Market Development Division, Scientific Knowledge & Information resources, Affiliate’s Pharmacovigilance and Commercial Partners and Services Providers.

Main activities:

• Participate to the Departmental meetings and cross-functional teams.

• Participate to interdepartmental meetings inside and outside R&D.

• Collaborate to draft Safety Data Exchange Agreements (SDEAs) with commercial Partners assuring consistency with the current legislation worldwide and Chiesi procedures.

• Monitor specific tools for PV intelligence purposes.

• Support on keeping SDEAs up-to-date by tracking any new agreement and its concerned termination/timelines for possible updates or renewals.

• Support PV contracts compliance with relevant GPV policies and proceduresx.

• Perform data entry of Agreements data into the relevant database for assuring PSMF proper update and up to date data exchange with contractual partners.

• Support in the management of the relevant annex of the Pharmacovigilance System Master File (PSMF).

• Collaborate in development and maintenance Standard Operating Procedures and Working Instructions in the field and support in the training administration.

• Collaborate in deviations management when they are related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation.

• Support in audit and inspection activities.

Education: Master Degree in scientific disciplines (CTF, Pharmacy, Biology, Biotechnology) with a post master's degree in Pharmacovigilance or Regulatory Affairs will be consider a plus.

Technical Skill:

• Basic knowledge on pharmacovigilance guidance in Europe and extra Europe.

• Microsoft Office suite proficiency.

Soft skills:

• Good planning and organizational skills.

• Ability to analyse, synthesise and to link and interpret different information.

• Ability to work in a team.

Languages: English: Excellent level. Study experience abroad is a plus.

Contract: 6 months internship. Reimbursement of expenses and meal vouchers.

Location: Parma.