Job Description
Target PR Range:
87-97/hr Summary of Position:
The Senior Manager, Pharmacovigilance (PV) Compliance supports the development, implementation, and oversight of the global PV compliance program to ensure adherence with applicable global regulatory requirements, industry standards, internal procedures, and contractual obligations. This role partners cross-functionally with PV Operations, Clinical Safety, Regulatory Affairs, Quality Assurance, and external vendors to support inspection readiness, quality oversight, procedural compliance, and continuous improvement activities across the PV system. Position Responsibilities:
Support the maintenance and continuous improvement of the global PV Quality Management System (QMS), including SOPs, work instructions, forms, and controlled documents. Perform oversight of outsourced PV activities and support vendor compliance management activities, including review of KPIs, metrics, deviations, CAPAs, reconciliations, and quality trends. Support inspection readiness activities for global health authority inspections, partner audits, and internal audits/mock inspections. Participate in the management and tracking of PV deviations, investigations, CAPAs, effectiveness checks, and quality events to ensure timely closure and regulatory compliance. Support periodic review and analysis of PV compliance metrics and quality trends to identify potential risks, gaps, and continuous improvement opportunities. Collaborate with cross-functional stakeholders and vendors to ensure implementation of applicable global PV regulatory requirements and procedural updates. Support maintenance activities related to the PSMF and associated annexes, as applicable. Support global expansion and launch readiness activities from a pharmacovigilance compliance perspective, including implementation of regional PV requirements, local compliance processes, and vendor oversight activities. Contribute to PV training compliance activities, including curriculum management, procedural training assignments, and training effectiveness support. Support compliance oversight activities related to Organized Data collection programs (ODCP), including review of program assessments, contractual PV requirements, procedural compliance, and applicable safety reporting obligations. Support compliance oversight of aggregate safety reporting activities, safety reporting processes, literature surveillance, and regulatory submission compliance, as applicable. Assist with the development and execution of risk-based compliance monitoring and quality review activities. Support governance meetings, compliance presentations, and preparation of compliance summaries for management review. Ensure activities are performed in accordance with applicable global regulations, GVP requirements, company policies, and PV agreements. Candidate Requirements:
Bachelor's degree in life sciences, pharmacy, nursing, or related scientific discipline. Minimum 6-8 years of experience in pharmacovigilance and/or PV compliance within the biotechnology or pharmaceutical industry. Working knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, ICH, and GVP requirements. Experience supporting inspections, audits, CAPAs, and vendor oversight activities preferred. Strong organizational, communication, and cross-functional collaboration skills. Experience with safety databases, document management systems, and compliance tracking tools preferred. •CO/NYC candidates might not be considered
