New Jersey Licensed Medical Safety Director

Job Summary

Leading safety activities and benefit-risk strategies for assigned compounds, the full-time New Jersey Licensed Medical Safety Director will oversee safety review documents, manage signal evaluations, and act as the Safety Subject Matter Expert while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities

• Lead safety activities and chair the product Safety Management Team(s) for assigned compounds
• Oversee the preparation and review of aggregate safety review documents and regulatory filings
• Manage signal evaluation and develop strategies for safety labeling activities

Required qualifications

• MD or equivalent required; postgraduate qualification in internal medicine, immunology, oncology, or related specialty preferred
• 3+ years of experience in pharmacovigilance or relevant pharmaceutical/biomedical fields
• Understanding of the drug development process and regulatory requirements for safety assessment
• Proficient in evaluating safety concerns and minimizing patient risk throughout a drug's lifecycle
• Strong scientific analytical reasoning skills and ability to manage multiple projects simultaneously