Manager, Pharmacovigilance Case Processing

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 SummaryThe Manager, Pharmacovigilance Case Processing is responsible for overseeing the end-to-end management of pharmacovigilance cases outsourced to a vendor, encompassing activities from initial collection to final submission. This role involves close collaboration with internal pharmacovigilance representatives, external case processing vendors, and various cross-functional teams. Primary ResponsibilitiesMonitoring Outsourced Activities & Case Management:Manage pre- and post-marketing pharmacovigilance cases processed by Service provider: book-in, data entry, coding, narratives, quality control, medical review, and submission of applicable cases.Ensure compliance with regulatory requirements, Safety Data Exchange Agreements (SDEA), and internal procedures.Perform weekly quality control of cases processed by vendors.Draft and validate deviation forms, root cause analysis, and CAPAs for cases submitted late to Regulatory authorities and other applicable recipientsClinical Trial Support & Documentation:Review protocols and electronic case report forms (eCRFs); write Safety Management Plans (SMP) for clinical trials.Request updates for ARGUS database configurations (studies, products, reporting rules, etc.,).Provide necessary documentation and training to vendors to ensure high-quality outsourced activities.Coordination & Oversight:Perform reconciliation with business partners, Local Pharmacovigilance teams (LPVs), and clinical databases.Participate in study kick-off/end meetings, operational meetings with vendors/business partners, and in audits/inspections as a Subject Matter Expert (SME).Contribute to process optimization, quality document writing, and the validation of vendor invoices.Education and Required SkillsBachelor’s degree in Life Science or a PharmD, preferably a healthcare professional (e.g., Medicine, Pharmacy, or Life Sciences).Minimum of 4 years of experience in pharmacovigilance case management, involving investigational drugs and/or approved products with end-to-end adverse event management in prominent global safety databases.Strong working knowledge of international pharmacovigilance (PV) regulations and reporting requirementsHands-on experience with pharmacovigilance databases (e.g., ARGUS) and other safety information systemsUnderstanding of literature review processes for safety signal identificationDemonstrated experience in quality control, CAPA management, and KPI development/monitoring for case processing activitiesProven ability to manage outsourced PV activities, including performance monitoring and training of external partners/Local pharmacovigilance teams (LPVs)Ability to collaborate effectively across global teams and serve as SME during audits and/or inspections.Travel and LocationHybrid model preferred, with 2-3 days a week in the Boston officeOccasional travel to the France headquarters may be requiredJob DescriptionCandidate ProfileServier’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.Salary RangeThe salary range for this role is $131,000 - $150,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link.