Manager, Pharmacovigilance Case Processing

SERVIER MONDE•Boston, MA

6d•$131,000 - $150,000•Hybrid

About The Position

The 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.

Requirements

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.

Responsibilities

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.
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 in audits/inspections as a Subject Matter Expert (SME).
Contribute to process optimization, quality document writing, and the validation of vendor invoices.