Senior Medical Director, Drug Safety and Pharmacovigilance

Responsibilities

• Provide medical oversight of safety vendors to ensure quality and compliance of outsourced activities
• Perform medical triage, safety assessment of case reports, and signal detection
• Review incoming adverse event reports to ensure prompt follow-up and timely submission of expedited safety reports
• Participate in the development and maintenance of SOPs, plans, and guidance documents to ensure GVP compliance
• Support safety inspection readiness and serve as a subject matter expert for internal audits and global inspections
• Review and provide input on safety sections of clinical documents including protocols, Investigator Brochures, and Informed Consents
• Lead or contribute to the preparation and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• Perform safety signal management and benefit-risk assessment activities

Requirements

• 10+ years of drug safety or pharmacovigilance experience in a sponsor or CRO environment
• Medical degree (MD)
• Comprehensive knowledge of global drug safety regulations and work practices
• Extensive experience with commercial safety databases such as Argus or ARIS-G
• Experience preparing aggregate reports including DSUR, PSUR/PBRER, PADER, RMP, and ISS
• Excellent knowledge of MedDRA and WHO Drug coding practices
• Strong project management and multitasking skills

Preferred Qualifications

• 3+ years of clinical physician experience treating solid cancers
• Training in medical or radiation oncology, hematology, or related fields
• NDA and MAA filing experience
• Strong scientific and analytical skills to interpret medical safety data
• Experience with audit readiness and preparedness activities

About the Company

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications.