Associate Director, Drug Safety and Pharmacovigilance
Celcuity
August 19, 2026
Remote friendly (Minneapolis, MN)
United States
Medical Affairs
Responsibilities:
- Provide strategic and operational leadership for clinical safety activities across assigned programs and oversee end-to-end safety operations (case processing, regulatory reporting, safety management plans, DSMB deliverables, safety data reconciliation).
- Provide leadership and oversight of external safety vendors to ensure high-quality, timely, compliant execution of outsourced safety activities.
- Lead preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage timelines and cross-functional inputs.
- Provide day-to-day direction to the Safety Operations team and communicate program-level updates to stakeholders.
- Oversee review/assessment of adverse event reports and ensure appropriate follow-up and timely expedited reporting per global regulations.
- Contribute to development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems.
- Ensure procedural deviations are documented, investigated, and addressed through corrective and preventive actions.
- Support inspection readiness and contribute during audits and health authority inspections.
- Develop and maintain study-specific safety management plans and related documents; ensure clear responsibility delineation between sponsor and CRO partners.
- Ensure adherence to Safety Data Exchange Agreements and all reporting requirements/timelines.
- Review and provide expert input on safety-related 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 required tasks.
Qualifications:
- 10+ years drug safety/pharmacovigilance experience in sponsor or sponsor/CRO roles.
- Bachelor’s or advanced degree in a life science/healthcare discipline (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 (DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
- Strong knowledge of MedDRA and WHODrug coding.
- Excellent written/verbal communication; strong interpersonal skills.
- Exceptional attention to detail; ability to manage multiple priorities.
- Advanced MS Office (Word, Excel, PowerPoint).
- Ability to work independently/collaboratively with sound judgment; initiative and continuous improvement mindset.
Benefits:
- Annual performance incentive bonus; new hire equity package; medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.
- Provide strategic and operational leadership for clinical safety activities across assigned programs and oversee end-to-end safety operations (case processing, regulatory reporting, safety management plans, DSMB deliverables, safety data reconciliation).
- Provide leadership and oversight of external safety vendors to ensure high-quality, timely, compliant execution of outsourced safety activities.
- Lead preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage timelines and cross-functional inputs.
- Provide day-to-day direction to the Safety Operations team and communicate program-level updates to stakeholders.
- Oversee review/assessment of adverse event reports and ensure appropriate follow-up and timely expedited reporting per global regulations.
- Contribute to development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems.
- Ensure procedural deviations are documented, investigated, and addressed through corrective and preventive actions.
- Support inspection readiness and contribute during audits and health authority inspections.
- Develop and maintain study-specific safety management plans and related documents; ensure clear responsibility delineation between sponsor and CRO partners.
- Ensure adherence to Safety Data Exchange Agreements and all reporting requirements/timelines.
- Review and provide expert input on safety-related 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 required tasks.
Qualifications:
- 10+ years drug safety/pharmacovigilance experience in sponsor or sponsor/CRO roles.
- Bachelor’s or advanced degree in a life science/healthcare discipline (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 (DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
- Strong knowledge of MedDRA and WHODrug coding.
- Excellent written/verbal communication; strong interpersonal skills.
- Exceptional attention to detail; ability to manage multiple priorities.
- Advanced MS Office (Word, Excel, PowerPoint).
- Ability to work independently/collaboratively with sound judgment; initiative and continuous improvement mindset.
Benefits:
- Annual performance incentive bonus; new hire equity package; medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.