Senior Area Safety Officer, Local PV - France

Job description

Senior Area Safety Officer, Local PV France and French Speaking Countries The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners. They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility. PRINCIPAL RESPONSIBILITIES: Oversight of the PV System & Overall responsibilities - Provide oversight of vendor resources in the countries in scope. - Support the Area Safety Head in providing relevant local information for the European Economic Area/ UK Pharmacovigilance System Master File (PSMF). - Regularly review the French PSMF and suggest necessary updates. - Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs). - Provide regular reporting of the local...