Director, Local Pharmacovigilance

Select how often (in days) to receive an alert:Type of Contract: Full-time Employment / UnlimitedJob Requisition ID: 9308Director, Local PharmacovigilanceAbout ServierServier 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 SummaryThe 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 ResponsibilitiesLead 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 regulationsMaintain oversight of safety risk management and of all pharmacovigilance activities in the territoryPrepare and maintain local PV procedures in compliance with Global SOPs and local regulationsEnsure 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 appropriatelyHire, 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 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 management.Specific Responsibilities for Post-Marketing PharmacovigilanceEnsure 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 timelinesEnsure 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 timeframes established in PHARMA-SOP-005; monitor the timelines of transmissionEnsure collection, review and follow up of safety information for products available under Early Access Programs (i.e. compassionate use) and transmission to Global SafetyEnsure direct contact with the Healthcare Professionals (HCP) to accurately document the PV cases, where necessary, and monitor the follow-up requests timelinesElectronic submission of ICSRs to the FDA, maintaining a log of data collected and transmitted to the Regulatory Agency, and monitoring compliance of ICSR submissionsEnsure 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 AffairsEnsure screening of local scientific journals not indexed in any of the international literature databases and collection of the corresponding safety informationReview 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 programEnsure oversight of signal evaluation report posted in WRA Portal by Global SafetyEnsure the PV training of local employees and collaborators; KPI related to affiliate's employee PV training will be documented and provided to the EEA-QPPV for oversightEnsure compliance with the local regulatory requirements 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 pharmacovigilance impactMonitor the compliance of any locally outsourced PV activityEnsure monthly reconciliation with functions responsible for products complaints/ quality defects and medical informationEnsure monthly reconciliations with other Servier functions and with service providers that can be sources of PV informationMaintain a list of the internet and digital media websites existing in the territory and share this information with the Global Safety International Unit upon requestParticipate in internal audits of the local system of pharmacovigilance and in inspections performed by the Regulatory Agency (in collaboration with the concerned departments); implement the CAPA plan within the defined timelinesArchive local PV documents (safety/ICSRs data and records) according to local pharmacovigilance regulatory requirements and data protection rulesSet up and maintain a Business Continuity Plan (BCP), in collaboration with the dotted line manager (including management of ICSRs and a local 24/7 system to collect any 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 sense of confidentialityExcellent analytical and critical investigative skillsCapacity to synthesize complex dataExceptional organizational and project management skills, with the ability to handle multiple complex priorities and deadlinesExceptional communication and presentation skills with the ability to distill complex safety data into actionable insightsExperience managing teams, demonstrated cross-functional leadership skills, and the ability to thrive within a matrix organizational structureExperience in people management and developmentTravel and LocationBoston-based preferred (onsite in Seaport office 2-3x per week)Minimal travel as requiredServier’s CommitmentServier 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. #J-18808-Ljbffr

Created: 2025-09-17