Pharmacovigilance Operations Manager

Full-time Bio & Pharmacology & Health, Management & Operations

Responsibilities

• Lead global Patient Safety Operations and manage safety surveillance projects for prescription drugs, medical devices, OTC drugs, and cosmetics
• Manage communications with vendors, CROs, QPPVs, and partners regarding case report evaluation and reconciliation
• Ensure safety reports are processed according to ICH-GCP guidelines, regulatory requirements, and company SOPs
• Maintain the company electronic safety reporting portal and the Pharmacovigilance System Master File (PSMF)
• Lead PV compliance monitoring and ensure continuous inspection and audit readiness
• Monitor and identify safety trends and signals through assessment of case reports and literature reviews
• Lead signal detection, analysis, and preparation of signal reports

Requirements

• Master's degree in Life Sciences, Pharmacology, Public Health, Nursing, or related field with 6–8+ years of PV experience, O...