Director, Pharmacovigilance

OverviewDirector, Local Pharmacovigilance (LPV) role at Servier Pharmaceuticals. The LPV Director (deputy local person responsible for pharmacovigilance) is part of the Medical Affairs Group, reporting to the Head of Local Pharmacovigilance and having a functional link with the European Economic Area Qualified Person for Pharmacovigilance (EEA QPPV). The LPV Director is responsible for maintaining an appropriate local PV system and for performing PV activities described in PHARMA-SOP-106. This role helps shape and execute the local pharmacovigilance strategy, drives regulatory compliance, and fosters a culture of safety excellence. Works closely with Medical Affairs, Global Safety, Regulatory Affairs, Field employees, and Market Access.Primary ResponsibilitiesLead the local PV function to ensure timely receipt and accurate reporting of all safety issues within the portfolio, in compliance with internal procedures and local regulationsMaintain oversight of safety risk management and all pharmacovigilance activities in the territoryPrepare and maintain local PV procedures in compliance with Global SOPs and local regulationsEnsure that Servier Pharmaceuticals employees and collaborators receive an appropriate level of PV training, adapted to their role, to identify and process PV informationHire, develop, and retain a high-performing pharmacovigilance team. Oversee PV requirements for contracts governing Investigator-sponsored studies (ISS) and other post-marketing collaborations and initiativesEnsure pharmacovigilance compliance and inspection readiness across all affiliate functionsParticipate in inspections performed by Regulatory Agencies and in internal PV AuditsOther responsibilities as described in PHARMA-SOP-106 or as directed by the functional managementSpecific Responsibilities for Post-Marketing PharmacovigilanceEnsure implementation of a local Quality Management System (QMS) in line with global and local pharmacovigilance legislation, quality documents, and local needs; monitor the local quality document update timelinesEnsure collection, review, and follow-up of local PV information from post-marketing sources (spontaneous, solicited, literature, regulatory) and transmission of accurate and complete cases to Global Safety (GS), per PHARMA-SOP-005; monitor transmission timelinesEnsure collection, review and follow-up of safety information for products under Early Access Programs (compassionate use) and transmission to Global SafetyMaintain direct contact with Healthcare Professionals (HCP) to document PV cases, as needed, and monitor follow-up requests timelinesSubmit ICSRs to the FDA, if not performed centrally, maintain a log of data collected and transmitted, and monitor ICSR submission complianceCommunicate risk minimisation measures to all Servier staff and to HCPs as applicable, in collaboration with Regulatory AffairsScreen local scientific journals not indexed in international databases and collect corresponding safety information; review Post Authorization Programs for safety data managementOversee signal evaluation reports posted in WRA Portal by Global SafetyProvide PV training for local employees and collaborators; document KPIs related to affiliates’ PV training for oversightEnsure regulatory compliance and screening of regulatory intelligenceParticipate in establishing PV agreements with partners and PV provisions for contracts with sponsor-investigators and service providersBe informed of all local contracts with PV impact; monitor compliance of locally outsourced PV activityEnsure monthly reconciliations with product complaints/quality defects and medical information functionsEnsure monthly reconciliations with other Servier functions and service providers that contribute PV informationMaintain a list of internet and digital media sources in the territory and share with Global Safety International Unit as requestedParticipate in internal PV system audits and regulatory inspections; implement CAPA within defined timelinesArchive local PV documents (safety/ICSR data and records) per local PV regulatory requirements and data protectionSet up and maintain a Business Continuity Plan (BCP), in collaboration with the dotted line manager (including 24/7 system for collecting safety information)Education and Required SkillsMedical doctor (preferred) or clinical pharmacist with broad specialty and experience8+ years of experience in pharmacovigilance within the pharmaceutical or biotechnology industryStrong leadership skillsHigh personal ethical standards and strict confidentialityExcellent analytical and investigative skillsAbility to synthesize complex dataExceptional organizational and project management skills with the ability to handle multiple priorities and deadlinesExcellent communication and presentation skills with the ability to distill complex safety data into actionable insightsExperience managing teams, cross-functional leadership, and thriving in a matrix organizationExperience in people management and developmentTravel and LocationBoston-based, onsite in Seaport office 2-3x per weekMinimal travel as requiredServier’s CommitmentServier is committed to modeling diversity, equity, and inclusion within the industry. We foster an environment that maintains equitable treatment for all and welcome applicants who are passionate, committed, and innovative. We encourage candidates to apply to open roles and 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.Seniority levelDirectorEmployment typeFull-timeJob functionScience, Other, and ResearchIndustriesPharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr

Created: 2025-09-17