Hybrid Pharmacovigilance Case Manager – Vendor Oversight

Biopharma Careers; Boston (MA); Hybrid; USD 131,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

Unlimited sick time & flex time

Life and disability insurance

Recognition programs

Job summary

Servier in Boston seeks a Manager of Pharmacovigilance Case Processing to oversee end-to-end PV case handling with a vendor. The role collaborates with internal PV teams, external case processing vendors, and cross-functional partners to ensure compliant, timely submissions.

Qualified candidates have 4+ years in PV case management, strong PV regulatory knowledge, and experience with safety databases like ARGUS. Hybrid work includes 2–3 days in the office with occasional travel to France.

Qualifications

• Bachelor’s degree in Life Science or PharmD, healthcare professional preferred.
• Minimum 4 years’ pharmacovigilance case management experience with end-to-end AE handling.
• Strong knowledge of PV regulations and global reporting requirements.

Responsibilities

• Oversee end-to-end PV case processing by vendor from collection to submission.
• Ensure compliance with SDEA, regulatory requirements, and internal procedures.
• Perform weekly quality control of vendor-processed cases.
• Draft deviation forms, root cause analyses, and CAPAs for late submissions.
• Review protocols, eCRFs, and SMPs; support ARGUS configurations and training for vendors.
• Coordinate with LPVs, study teams, and audits as a PV SME.

Skills

PV case mgmt

Regulatory knowledge

Vendor management

Cross-functional collab

Safety databases (ARGUS)

Education

Bachelor’s degree in Life Science or PharmD

Tools

ARGUS

Job description

Servier in Boston seeks a Manager of Pharmacovigilance Case Processing to oversee end-to-end PV case handling with a vendor. The role collaborates with internal PV teams, external case processing vendors, and cross-functional partners to ensure compliant, timely submissions.

Qualified candidates have 4+ years in PV case management, strong PV regulatory knowledge, and experience with safety databases like ARGUS. Hybrid work includes 2–3 days in the office with occasional travel to France.