Associate Director, Drug Safety and Pharmacovigilance

Responsibilities

• Provide leadership and oversight of external safety vendors to ensure high‑quality, timely, and compliant execution of all outsourced safety activities.
• Lead the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs.
• Provide day‑to‑day direction to the Safety Operations team and communicate program‑level updates to internal and external stakeholders.
• Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership when additional insight or alignment is needed.
• Oversee the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and timely expedited reporting in accordance with global regulatory requirements.
• Contribute to the development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices.
• Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions.
• Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections.
• Develop and maintain study‑specific safety management plans and related documents, ensuring clear delineation of responsibilities between Celcuity and CRO partners.
• Ensure adherence to Safety Data Exchange Agreements and compliance with all agreed‑upon reporting requirements and timelines.
• 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 key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive continuous improvement.
• Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices.
• Perform other tasks as required to assist in company and departmental activities.

• 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 working 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, with the ability to convey complex information clearly and concisely.
• Strong interpersonal skills with the ability to collaborate effectively 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.
• Naturally takes initiative, contributing to continuous improvement efforts and proactively identifying opportunities to enhance processes within the department.
• Continuous improvement mindset with a focus on innovation, efficiency, and operational excellence.
• Flexible, adaptable, and committed to maintaining a positive and professional demeanor.

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA‑approved product is REVTORPYK (gedatolisib), a potent, pan‑PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with…