Senior Manager PV Operations (Waltham)

Postion Summary :

This role is responsible for the day-to-day operational oversight of safety case processing conducted by external vendors, ensuring high-quality deliverables that align with internal SOPs, global regulations, and industry best practices. The Senior Manager will collaborate cross-functionally to maintain compliant and efficient safety operations across the organization.

Experience, Knowledge & Abilities

• Minimum 5 years of relevant experience in the biotechnology or pharmaceutical industry
• At least 3 years of hands-on experience in Drug Safety / Pharmacovigilance
• Prior experience managing CROs, vendors, and external relationships strongly preferred
• Demonstrated experience in global PV operations supporting products in clinical development
• Strong understanding of safety databases (Argus), case reconciliation processes, and QC methodologies.

Education :

Bachelors degree in nursing, pharmacy, or other health care related profession or life sciences.