Senior Manager – Pharmacovigilance Quality Assurance
Location: Cambridge, MA (onsite) Contract: 1+ Year
Position Summary:
Our client is seeking a Senior Manager with strong experience in Pharmacovigilance Quality and Compliance to support the quality management of global drug safety operations. This role will focus on maintaining regulatory compliance, managing quality activities, overseeing external partners, and ensuring the organization is prepared for regulatory inspections.
Responsibilities:
Provide quality oversight across global pharmacovigilance and post-marketing safety programs.
Coordinate and participate in internal, external, and vendor-related PV audits.
Evaluate quality issues and lead investigations, root-cause analysis, corrective actions, and CAPA activities.
Track compliance activities and identify potential risks or gaps within PV processes.
Support preparation for FDA and other health authority inspections, including inspection-related documentation and follow-up activities.
Contribute to the maintenance and ongoing compliance of the Pharmacovigilance System Master File (PSMF).Manage quality oversight of third-party PV service providers, including performance monitoring and quality agreements.
Review compliance trends, metrics, and quality indicators and recommend appropriate improvements.
Work closely with Pharmacovigilance, Regulatory, Clinical, Quality, and other functional teams on compliance initiatives.
Help strengthen PV quality systems, procedures, and processes through continuous improvement activities.
Ensure pharmacovigilance practices remain consistent with GVP, FDA, ICH, and applicable international regulations.
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Biology, or a related scientific discipline. Strong industry background in Pharmacovigilance, Drug Safety, Quality
