Director, Local Pharmacovigilance

Director, Local Pharmacovigilance About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting‑edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.

The Director, Local Pharmacovigilance (LPV) is part of the Medical Affairs Group, reporting to the Head of Local Pharmacovigilance and also having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV – dotted line reporting). The LPV Director (deputy local person responsible for pharmacovigilance) is responsible for maintaining an appropriate local PV system and for performing PV activities as described in PHARMA‑SOP‑106.

This individual will help shape and execute the local pharmacovigilance strategy, drive compliance with regulatory requirements, and foster a culture of safety excellence within the organization. The role works closely with medical affairs colleagues and cross‑functional colleagues such as Global Safety, Regulatory Affairs, Field employees, and Market Access.

• Lead the local PV function to ensure the timely receipt and accurate reporting of all safety issues within the portfolio, in compliance with internal procedures and local regulations
• Maintain oversight of safety risk management and of all pharmacovigilance activities in the territory
• Prepare and maintain local PV procedures in compliance with Global SOPs and local regulations
• Ensure that all Servier Pharmaceuticals employees and collaborators receive an level of PV training, adapted to their role, and which will enable them to identify and process PV information appropriately
• Hire, develop, and retain a high‑performing pharmacovigilance team. Oversee the PV requirements for contracts governing Investigator‑Sponsored Studies (ISS) and other post‑marketing collaborations and initiatives
• Ensure pharmacovigilance compliance and inspection readiness across all affiliate functions
• Participate in inspections performed by Regulatory Agencies and in internal PV Audits
• Other responsibilities as described in PHARMA‑SOP‑106 or as directed by the functional management

• Ensure implementation of a local Quality Management System (QMS) in line with the global and local pharmacovigilance legislation, quality documents, and local needs; monitor the local quality document update timelines
• Ensure collection, review, and follow‑up of local PV information received from all post‑marketing sources (spontaneous, solicited, literature, regulatory) and transmission of accurate and complete cases to Global Safety (GS), in compliance with the time frames established in PHARMA‑SOP‑005; monitor the timelines of transmission
• Ensure collection, review and follow‑up of safety information for products available under Early Access Programs (i.e., compassionate use) and transmission to Global Safety
• Ensure direct contact with Healthcare Professionals (HCP) to accurately document the PV cases, where necessary, and monitor the follow‑up requests timelines
• Electronic submission of ICSDs to the FDA, maintaining a log of data collected and transmitted to the Regulatory Agency, and monitoring compliance of ICSR submissions
• Ensure that the information on the risk minimisation measures is delivered to all Servier staff as well as to HCP if applicable, in collaboration with the responsible person for Regulatory Affairs
• Ensure screening of local scientific journals not indexed in any of the international literature databases and collection of the corresponding safety information
• Review of the Post‑Authorization Programs with regards to collection, notification and management of safety data, considering the Risk Management Plan (if applicable) and the type of program
• Ensure oversight of signal evaluation report posted in WRA Portal by Global Safety
• Ensure the PV training of local employees and collaborators; KPI related to affiliate's employee PV training will be documented and provided to the…