Associate Director, Drug Safety and Pharmacovigilance
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Job Description
Associate Director leading drug safety and pharmacovigilance for Celcuity’s targeted cancer therapies. Overseeing clinical safety operations, vendors, regulatory reporting, and inspection readiness.
Responsibilities:
- Provide strategic and operational leadership for clinical safety activities across assigned programs
- Provide proactive oversight of end-to-end safety operations, including case processing, regulatory reporting, safety management plans, DSMB deliverables, and safety data reconciliation
- Lead and oversee external safety vendors to ensure high-quality, timely, and compliant execution of outsourced safety activities
- Lead preparation, authorship, and review of aggregate safety reports, including DSURs, PADERs, and line listings
- Manage aggregate-report timelines and cross-functional inputs
- Provide day-to-day direction to the Safety Operations team and communicate program updates to stakeholders
- Review and assess adverse event reports, ensuring appropriate follow-up and timely expedited reporting under global regulatory requirements
- Contribute to and continuously improve SOPs, work instructions, templates, and systems
- Ensure procedural deviations are documented, investigated, and addressed through corrective and preventive actions
- Support inspection readiness, audits, and global health authority inspections
- Develop and maintain study-specific safety management plans and related documents
- Ensure adherence to Safety Data Exchange Agreements and reporting requirements
- Review and provide expert input on safety-related sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms
- Develop, monitor, and interpret KPIs and metrics for internal teams and external vendors
- Serve as a safety subject matter expert for internal teams and external stakeholders
- Perform other tasks as required to assist in company and departmental activities
Requirements:
- 10+ years of drug safety/pharmacovigilance experience within a sponsor environment or a combination of sponsor and CRO roles
- Bachelor’s or advanced degree in a life science or healthcare-related discipline (e.g., MD, RN, PharmD, NP, PhD, MPH)
- Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices
- Extensive experience with commercial safety databases (Argus or ARIS-G), electronic data capture systems, and trial master files
- Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates
- Strong knowledge of MedDRA and WHODrug coding conventions
- Excellent written and verbal communication skills
- Strong interpersonal skills and ability to collaborate across functions and organizational levels
- Exceptional attention to detail and ability to manage multiple priorities and documentation requirements
- Strong technical and analytical skills with advanced proficiency in MS Office (Word, Excel, PowerPoint)
- Ability to work independently or collaboratively, demonstrating sound judgment and decision-making in a fast-paced environment
- Initiative and continuous improvement mindset focused on innovation, efficiency, and operational excellence
- Flexible, adaptable, and committed to maintaining a positive and professional demeanor
Benefits:
- Annual performance incentive bonus
- New hire equity package
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- PTO
- Paid holidays
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