Associate Director, Drug Safety and Pharmacovigilance

Responsibilities

• Provide strategic and operational leadership for clinical safety activities and oversight of external safety vendors
• Lead the preparation, authorship, and review of aggregate safety reports such as DSURs and PADERs
• Oversee the review and assessment of adverse event reports to ensure timely expedited reporting
• Develop and maintain study-specific safety management plans and related clinical documents
• Contribute to the development and continuous improvement of SOPs, work instructions, and systems
• Support inspection readiness and serve as a key contributor during audits and health authority inspections
• Monitor and interpret key performance indicators for internal teams and external vendors

Requirements

• 10+ years of drug safety or pharmacovigilance experience in a sponsor or CRO environment
• Bachelor's or advanced degree in life sciences or healthcare (MD, RN, PharmD, NP, PhD, MPH)
• Comprehensive knowledge of global clinical safety regulations and industry best practices
• Extensive experience with commercial safety databases like Argus or ARIS-G
• Demonstrated experience preparing aggregate safety reports (DSURs, PSUR/PBRERs, PADERs)
• Strong knowledge of MedDRA and WHODrug coding conventions
• Proficiency in MS Office

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.