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.

Role Summary

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 be responsible for helping to shape and execute the local pharmacovigilance strategy, driving compliance with regulatory requirements, and fostering a culture of safety excellence within the organization. This role will work closely with medical affairs colleagues and cross functional colleagues such as Global Safety, Regulatory Affairs, Field employees, and Market Access.

Primary Responsibilities

• 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 appropriate 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.

Specific Responsibilities for Post-Marketing Pharmacovigilance

Education and Required Skills

Excellent analytical and critical investigative skills

Travel and Location

Servier's Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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