Global safety benefit & Risk Director - Permanent contract

My client, major pharmaceutical laboratory is looking for a Global safety benefit & Risk Director based in Paris who will be accountable for overseeing signal detection, risk management systems, responses to regulatory inquiries, safety communication, and managing safety aspects in various study contexts. The role involves ensuring compliance with internal Standard Operating Procedures (SOPs) and global regulatory requirements. Additionally, the director acts as the Deputy EEA QPPV.

Responsibilities:

Lead and strategize the Safety Benefit/Risk team across and other locations around the world, fostering a well-functioning and motivated team. Provide strategic guidance for internal governance processes, cross-functional activities, and external contractual relationships related to the Benefit/Risk evaluation unit portfolio. Manage the signal detection process including detection, analysis, validation, and communication, proposing subsequent actions in line with regulations. Oversee and provide strategic guidance for risk management plans and activities, including risk minimization measures. Ensure the review and approval of periodic safety update reports required at the international level (PSUR, PBRER, DSUR, etc.) and expert reports for MA variation applications for safety reasons. Contribute to and review study protocols and related documents for interventional, non-interventional, and other programs. Ensure contribution to and review of the safety part of the MAA dossier. Coordinate team actions in crisis management related to product risk management and safety. Ensure unit participation in scientific monitoring activities such as bibliography, congresses, and expert contacts. Represent the Benefit/Risk evaluation unit as needed at Benefit/Risk and Labelling Committee or other ad hoc meetings. Provide oversight and support in the preparation and review of safety sections of clinical documents, ensuring compliance with Health Authority requirements. Act as the deputy of the EEA QPPV.

Qualifications and Experience:

Medical degree strongly preferred. At least 15 years of experience in the pharmaceutical industry in the PV field, including clinical and post-marketing settings, with expertise in analyzing PV data, especially for products covered by a risk management plan. Expert knowledge of PV processes and international regulatory requirements. Ability to represent the EEA QPPV

Full proficiency in English.