Pharmacovigilance Operations Manager

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, OR Bachelor's degree with 8+ years of experience
• Progressive experience in pharmaceutical, biotechnology, or medical device environments
• Direct experience in end-to-end case processing and ICSR/MDR lifecycle management
• Proficiency with safety databases (Argus preferred)
• Experience with signal detection and safety surveillance activities
• Strong understanding of global GVP regulations and ICH guidelines
• Ability to analyze safety data and assess clinical relevance

Preferred Qualifications

• MD, PhD, or PharmD with 2+ years of clinical/academic experience and 3+ years of patient safety experience
• Understanding of audit and inspection management, Risk Management Plans (RMPs), and CCDS development
• Hands-on experience with regulatory inspections and internal/external audits
• Experience developing aggregate reports (PSUR/PBRER, DSUR)

About the Company

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics, driven by science-powered innovation.