Assistant Manager-PV

Position Summary
The Pharmacovigilance Oversight Assistant Manager is responsible for providing operational oversight of pharmacovigilance activities performed by

external service providers , primarily Contract Research Organizations (CROs) and vendors. This role ensures that all pharmacovigilance activities are conducted in compliance with global regulatory requirements, company procedures, and applicable safety agreements, maintaining the integrity and quality of the company’s safety data and reporting obligations.

Key Responsibilities
CRO Oversight & Governance
Serve as the primary point of contact for pharmacovigilance-related activities outsourced to CROs and vendors.
Oversee the implementation and ongoing performance of pharmacovigilance service agreements and Safety Data Exchange Agreements (SDEAs).
Monitor CRO performance metrics, compliance indicators, and quality deliverables.
Participate in governance meetings and conduct regular reviews of PV operations with the CRO.
Quality & Compliance
Ensure CROs operate in accordance with global regulatory requirements (e.g., FDA, EMA, MHRA, ICH, GVP, CIOMS) and company SOPs.
Conduct and support audits, inspections, and compliance checks related to outsourced PV activities.
Identify and manage deviations, CAPAs, and process improvements.
Safety Case Management Oversight
Review CRO handling of Individual Case Safety Reports (ICSRs), expedited reporting, and aggregate data submissions.
Ensure adherence to case processing timelines, data integrity, and accurate entry into safety databases.
Signal Management and Risk Minimization
Oversee CRO activities related to signal detection, evaluation, and documentation.
Support the internal safety team in ongoing risk management activities and periodic safety updates.
Documentation & Reporting
Review and approve safety management plans (SMPs), pharmacovigilance system master files (PSMFs), and relevant SOPs.
Maintain oversight documentation demonstrating compliance and due diligence.
Draft PSUR and RMP as per the global regulatory requirements
Cross-functional Collaboration
Work closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and Medical Affairs to ensure integration of safety oversight into all phases of product development.
Support internal training and awareness on outsourced PV responsibilities and expectations