Sr. Manager, PV Quality & Compliance

Senior Manager, PV Quality & Compliance (Contractor)

Our Waltham based pharmaceutical client is seeking a Senior Manager, PV Quality & Compliance to lead pharmacovigilance quality and compliance activities, ensuring global inspection readiness, regulatory compliance, and effective oversight of PV systems, vendors, and business partners.

Key Responsibilities

• Lead PV audit and inspection readiness activities, including gap assessments, SME preparation, and inspection support.
• Oversee the PV Quality Management System (QMS), including controlled documents, quality events, investigations, CAPAs, and compliance monitoring.
• Support development and maintenance of the Pharmacovigilance System Master File (PSMF).
• Manage PV vendor oversight, quality management plans, PV agreements, governance activities, and partner compliance.
• Drive PV training governance, qualification compliance, and training effectiveness programs.
• Monitor PV metrics and KPIs, identify trends, and support continuous improvement initiatives.

Qualifications

• Bachelor's degree and 8 years of pharmacovigilance experience within the pharmaceutical or biotechnology industry.
• Strong GxP Quality and GVP compliance experience.
• Experience overseeing clinical and commercial PV vendors.
• In-depth knowledge of FDA, EMA, and ICH pharmacovigilance regulations.
• Strong communication, problem-solving, organizational, and stakeholder management skills.
• Ability to thrive in a fast-paced, highly regulated environment.

Preferred

• Experience with ICSR processing, aggregate reporting, and safety databases such as Argus.
• Experience supporting global PV compliance programs and PSMF activities.

This is an excellent opportunity to play a key role in maintaining a robust global pharmacovigilance compliance framework while supporting inspection readiness and continuous quality improvement.