Associate Director, Drug Safety and Pharmacovigilance
Celcuity
July 03, 2026
Remote friendly (United States)
United States
Operations
Position Summary
- Associate Director, Drug Safety and Pharmacovigilance (reports to Executive Director). Provide strategic and operational leadership for clinical safety activities across assigned programs; oversee end-to-end safety operations for compliant safety oversight across clinical trials.
Responsibilities
- Lead and oversee external safety vendors for high-quality, timely, compliant execution of outsourced safety activities.
- Prepare, author, and review aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage timelines and cross-functional inputs.
- Provide day-to-day direction to Safety Operations; communicate program-level updates to internal/external stakeholders.
- Review and assess adverse event reports to ensure appropriate follow-up and timely expedited reporting per global regulatory requirements.
- Develop, implement, and continuously improve SOPs, work instructions, templates, and systems.
- Ensure procedural deviations are documented, investigated, and addressed with corrective and preventive actions.
- Support inspection readiness and contribute to audits and health authority inspections.
- Develop and maintain study-specific safety management plans and related documents, clarifying responsibilities between Celcuity and CRO partners.
- Ensure adherence to Safety Data Exchange Agreements and agreed reporting requirements/timelines.
- Provide expert input to safety sections of clinical documents (protocols, charters, Investigator Brochures, Informed Consent Forms).
- Develop, monitor, and interpret KPIs/metrics for internal teams and vendors.
- Serve as safety subject matter expert; perform other related tasks as needed.
Qualifications
- 10+ years drug safety/pharmacovigilance experience in a sponsor or sponsor/CRO environment.
- Bachelor’s or advanced degree (life science/healthcare-related; e.g., MD, RN, PharmD, NP, PhD, MPH).
- Comprehensive knowledge of global clinical safety regulations and best practices.
- Experience with Argus or ARIS-G, electronic data capture systems, and trial master files.
- Experience preparing aggregate safety reports (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
- Strong knowledge of MedDRA and WHODrug.
Skills
- Strong written/verbal communication and collaboration.
- Attention to detail; ability to manage multiple priorities and documentation.
- Advanced MS Office (Word, Excel, PowerPoint).
- Independent judgment; initiative and continuous improvement mindset.
- Flexible, adaptable, professional demeanor.
Benefits
- Annual performance incentive bonus; new hire equity package; medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
- Associate Director, Drug Safety and Pharmacovigilance (reports to Executive Director). Provide strategic and operational leadership for clinical safety activities across assigned programs; oversee end-to-end safety operations for compliant safety oversight across clinical trials.
Responsibilities
- Lead and oversee external safety vendors for high-quality, timely, compliant execution of outsourced safety activities.
- Prepare, author, and review aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage timelines and cross-functional inputs.
- Provide day-to-day direction to Safety Operations; communicate program-level updates to internal/external stakeholders.
- Review and assess adverse event reports to ensure appropriate follow-up and timely expedited reporting per global regulatory requirements.
- Develop, implement, and continuously improve SOPs, work instructions, templates, and systems.
- Ensure procedural deviations are documented, investigated, and addressed with corrective and preventive actions.
- Support inspection readiness and contribute to audits and health authority inspections.
- Develop and maintain study-specific safety management plans and related documents, clarifying responsibilities between Celcuity and CRO partners.
- Ensure adherence to Safety Data Exchange Agreements and agreed reporting requirements/timelines.
- Provide expert input to safety sections of clinical documents (protocols, charters, Investigator Brochures, Informed Consent Forms).
- Develop, monitor, and interpret KPIs/metrics for internal teams and vendors.
- Serve as safety subject matter expert; perform other related tasks as needed.
Qualifications
- 10+ years drug safety/pharmacovigilance experience in a sponsor or sponsor/CRO environment.
- Bachelor’s or advanced degree (life science/healthcare-related; e.g., MD, RN, PharmD, NP, PhD, MPH).
- Comprehensive knowledge of global clinical safety regulations and best practices.
- Experience with Argus or ARIS-G, electronic data capture systems, and trial master files.
- Experience preparing aggregate safety reports (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
- Strong knowledge of MedDRA and WHODrug.
Skills
- Strong written/verbal communication and collaboration.
- Attention to detail; ability to manage multiple priorities and documentation.
- Advanced MS Office (Word, Excel, PowerPoint).
- Independent judgment; initiative and continuous improvement mindset.
- Flexible, adaptable, professional demeanor.
Benefits
- Annual performance incentive bonus; new hire equity package; medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.