The intern, under the supervision of Global Pharmacovigilance Operation Department Manager, will involved in all the activities related to the Pharmavogilance agreement management. He/She 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 also Commercial Partners and Services Providers
- 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 procedures
- 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
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.
Basic knowledge on pharmacovigilance guidance in Europe and extra Europe
Proficient with Microsoft Office suite
- 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