Manager, Pharmacovigilance Case Processing

Date posted: August 6, 2026 • Boston, US • Full-time

About the role

The Manager, Pharmacovigilance Case Processing oversees the end-to-end management of pharmacovigilance cases outsourced to a vendor, from initial collection to final submission. This role involves close collaboration with internal pharmacovigilance representatives, external case processing vendors, and cross-functional teams.

Responsibilities

• Monitor pre- and post-marketing pharmacovigilance cases processed by the service provider, including 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.
• 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.
• 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 audits/inspections as a Subject Matter Expert (SME).
• Contribute to process optimization, quality document writing, and validation of vendor invoices.

Requirements

• Bachelor’s degree in Life Science or a PharmD; healthcare professional background (e.g., Medicine, Pharmacy, or Life Sciences) preferred.
• Minimum of 4 years of experience in pharmacovigilance case management, including investigational drugs and/or approved products with end-to-end adverse event management in 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.

Schedule

Hybrid model preferred, with 2-3 days a week in the Boston office. Occasional travel to the France headquarters may be required.

Pay

The salary range for this role is $131,000 - $150,000. An employee’s pay position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. Employees in this position are also eligible for Short-Term and Long-Term incentive programs.

Benefits

• Medical, dental, and vision coverage
• Flexible time off (unlimited sick time and flex time; no accrual)
• 401(k) retirement plan
• Life and disability insurance
• Recognition programs