Senior Medical Director, Drug Safety and Pharmacovigilance
Core
Lead medical oversight of drug safety and pharmacovigilance activities, including case report triage, signal detection, risk management, and regulatory reporting for marketed and investigational oncology products.
Role type
Senior Medical Director, Drug Safety and Pharmacovigilance
Builds
Safety data exchange agreements, safety systems, policies, and periodic safety reports for Celcuity's targeted cancer therapies
Domain
Biotechnology / Oncology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical degree, global drug safety regulations knowledge, adverse event review, aggregate safety report preparation (DSUR, PSUR, PADER), MedDRA/WHO Drug coding, safety database management (Argus/ARIS-G), vendor oversight, SOP development, inspection readiness, clinical document safety review, benefit-risk assessment
Preferred skills
Radiation oncology/hematology training, solid cancer clinical physician experience, NDA/MAA filing experience, audit readiness, data presentation and analysis
Technologies
Argus, ARIS-G, electronic data capture systems
Responsibilities
Oversee safety vendor activities and ensure compliance; review incoming adverse event reports and expedite safety submissions; develop and maintain safety SOPs and systems; support inspection readiness; review safety sections of clinical protocols and investigator brochures; lead safety information presentations to the Data Safety Monitoring Board; perform safety signal management and benefit-risk assessments
Seniority
Senior, hands-on IC with strategic oversight
