Associate Director, Drug Safety and Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide leadership and supervision of external safety vendors to ensure the effective, timely, and compliant execution of all outsourced safety operations.

• Lead the creation, authorship, and evaluation of aggregate safety reports (e.g., DSURs, PADERs, line listings) while managing associated timelines and cross-functional contributions.

• Offer daily guidance to the Safety Operations team and relay program-level updates to both internal and external stakeholders.

• Show initiative by identifying potential solutions and providing insightful recommendations, involving leadership for additional insights or alignment when necessary.

• Oversee the examination and evaluation of adverse event reports for assigned programs, ensuring appropriate follow-up and timely expedited reporting in compliance with global regulatory standards.

• Contribute to the creation, implementation, and ongoing enhancement of SOPs, work instructions, templates, and systems to ensure adherence to global clinical trial regulations and industry best practices.

• Ensure that procedural deviations are recorded, investigated, and resolved through effective corrective and preventive actions.

• Assist with inspection readiness activities and act as a key contributor during audits and inspections by global health authorities.

• Develop and maintain study-specific safety management plans and related documentation, ensuring clear allocation of responsibilities between Celcuity and CRO partners.

• Ensure compliance with Safety Data Exchange Agreements and 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 analyze key performance indicators and metrics for internal teams and external vendors to assess performance and promote continuous improvement.

• Act as the safety subject matter expert for internal teams and external stakeholders, offering guidance on safety operations, regulatory expectations, and best practices.

• Carry out other tasks as needed to support company and departmental initiatives.

⛳️ Requirements

• 10+ years of experience in drug safety/pharmacovigilance within a sponsor environment or a mix 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).

• In-depth understanding of global clinical safety regulations, guidelines, and industry best practices.

• Extensive experience using commercial safety databases (Argus or ARIS-G), electronic data capture systems, and trial master files.

• Proven experience in preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to Investigator Brochure updates.

• Strong familiarity with MedDRA and WHODrug coding conventions.

• Excellent written and verbal communication skills, capable of conveying complex information clearly and succinctly.

• Strong interpersonal skills with the ability to collaborate effectively across various functions and organizational levels.

• Exceptional attention to detail and the capability to manage multiple priorities and documentation requirements.

• Strong technical and analytical abilities with advanced proficiency in MS Office (Word, Excel, PowerPoint).

• Ability to work independently or as part of a team, exhibiting sound judgment and decision-making in a fast-paced environment.

• Proactively takes initiative, contributing to continuous improvement efforts and identifying opportunities to refine processes within the department.

• Continuous improvement mindset focused on innovation, efficiency, and operational excellence.

• Flexible, adaptable, and dedicated to maintaining a positive and professional demeanor.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k) match

• PTO

• Paid holidays

• Annual performance incentive bonus

• New hire equity package