Senior Pharmacovigilance Project Manager M/F
Machine translation — original language: French.Show original
We are looking for a Senior Pharmacovigilance Project Manager M/F starting from September 2026 for a mission within a prestigious pharmaceutical group. Our client is an international pharmaceutical laboratory based in Gif-sur-Yvette, committed to therapeutic progress for the benefit of patients, in close collaboration with healthcare professionals. Its growth is based on a constant search for innovation in several therapeutic areas.
Main responsibilities
- Collect and document PV notifications,
- Enter into the local database PV cases from all sources: spontaneous cases or solicited cases (from Investigator Sponsored Studies (ISS), post-authorization studies (PAS), compassionate use*), as well as from French scientific literature.
- Ensure the follow-up of PV cases,
- Anonymize received documents,
- Perform quality control and medical consistency review before transfer to the central database,
- Complete the tracker grouping all received PV notifications,
- Ensure the storage and archiving of pharmacovigilance data,
- Respond to questions from Global Safety (GS),
- Communicate with internal structures (France PV team and FAME CIRT, Global Safety, Medical Information, Global Medical & Patients Affairs) and external ones (ISS sponsor, CRO in charge of PAS studies, CRO in charge of compassionate use, etc.),
- Actively participate in the PV team dynamic,
- Contribute to the revision of local PV procedures, local signal detection, and the preparation of periodic reports within the framework of compassionate use,
- Participate in literature and regulatory monitoring,
- Contribute to the preparation of monthly reports for the Chief Pharmaceutical Officer.
Profile
- Bachelor's degree (BAC+3) in the field of pharmacovigilance (such as: professional license in pharmaco and other vigilances or master's in Clinical Development of the drug) or pharmacist
- Operational and fluent English,
- Mastery of the PV database (if possible ARGUS),
- 5 years of experience in PV case management within a private company in the pharmaceutical industry (laboratory or CRO),
- Mastery of the MedDRA dictionary
- Ability to perform reporting, alert, and provide feedback, with a good sense of priorities and organization in order to respect PV case processing deadlines, as well as an ability to adapt to organizational changes.
- Mastery of office tools (Outlook, Powerpoint, Excel, Word.)
Do you wish to join a dynamic and ambitious Group?
Does the position match your expectations and your skills?
Do not hesitate any longer and apply