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 recipients
Clinical 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 Skills- Bachelor'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 requirements
- Hands-on experience with pharmacovigilance databases (e.g., ARGUS) and other safety information systems
- Understanding of literature review processes for safety signal identification
- Demonstrated experience in quality control, CAPA management, and KPI development/monitoring for case processing activities
- Proven 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 Location- Hybrid model preferred, with 2-3 days a week in the Boston office
- Occasional travel to the France headquarters may be required
Job DescriptionCandidate ProfileSalary 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.
