Senior PV Specialist - Build a team and become a manager

Nonstop-Pharma is currently looking for a Senior Pharmacovigilance Specialist to join a growing company which combines local expertise with global reach in the area of Development Consulting, Regulatory Affairs, Pharmacovigilance, Epidemiology, Risk Management and Quality Management & Compliance.

With extensive experience in all major therapeutic areas and product groups including advanced therapy medicinal products, biopharmaceuticals, medicinal & borderline products as well as alternative therapeutic approaches, the company has a presence in more than 15 countries with a team of 700+ professionals.

This is the opportunity to tart a new challenge and contribute to the development of the PV department in order to manage all the post market PV activities for medicinal and Biotech products. As such, you will be leading a team of PV officer/specialist in a near future.

Missions:
- Implement and administrate PV systems
- Write and update project related Safety Management Plans/Safety Data Exchange Agreements
- Register and maintain Eudravigilance profiles
- Oversight of Case Management Process
- Review and update Periodic Safety Update Reports (DSURs/PSURs/PBRERs)
- Write and maintain Pharmacovigilance System Master Files (PSMF)
- Lead pharmacovigilance projects and coordinate project team activities
- Interact with clients and ensure compliance with the project scopes and budgets
- Contribute to the preparation of proposals
- Manage audits and inspections
- Write and keep pharmacovigilance procedures up to date

Profile:
- Completed Pharmacy degree, University Master or Engineer degree
- A minimum of 5 years of professional experience and, technical/project management experience
- Native French speaker and fluency in spoken and written English
- Knowledge about pre-market PV activities is be a plus

If you are interested in this position please contact Chloé Khatcherian on 00331 76 75 33 40 or send your CV in Word format to c.khatcherian@nonstop-pharma.com