New Jersey Licensed Pharmacovigilance Manager

Job Summary

Partnering with the Medical Safety Assessment Physician, the full-time New Jersey Licensed Pharmacovigilance Manager will manage signal detection activities, lead safety data review meetings, and ensure regulatory compliance while contributing to safety strategy and risk management for BMS medicines.

Key responsibilities

• Perform core signal detection and assessment activities throughout the product life cycle, including literature reviews and quantitative analysis
• Lead safety data review meetings and escalate issues impacting key safety management team activities and milestones
• Contribute to regulatory filings by preparing safety sections of marketing authorization applications and responding to health authority queries

Required qualifications

• Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or equivalent combination of education and experience
• Minimum of 4-6 years of relevant pharmacovigilance or pharmaceutical industry experience
• Working understanding of medical concepts and safety activities in drug development and postmarketing
• Ability to manage timelines and quality of work through effective communication and collaboration
• Familiarity with data analysis methods and emerging technologies to enhance workflows and compliance