Vice President, Drug Safety & Pharmacovigilance

Role Summary

Location: Remote. We are seeking a Vice President of Drug Safety & Pharmacovigilance who will report into the Chief Medical Officer. You will focus on developing and executing strategic vision for the Drug Safety and Pharmacovigilance department, aligning with the company’s goals and objectives and industry’s best practices for both investigational and marketed products.

Responsibilities

• Ensure competent medical evaluation of all relevant safety information, including information from business partners, regulatory agencies, clinical trials, scientific literature, and non-clinical studies for ongoing surveillance and signal detection.
• Proactively interact with clinical trial investigators and other medical staff to manage clinically important safety signals arising in clinical trials.
• Work with PV vendor and internal safety team to develop a system for post-marketing safety surveillance (US and EU).
• Lead Celcuity’s Safety Management Team and oversee all risk-benefit assessments to ensure oversight of the company’s medicinal products throughout their life cycle.
• Collaborate cross-functionally with Clinical Development, Regulatory, Clinical Operations, Medical Affairs, Quality, and Commercial teams to develop therapeutic area and product expertise.
• Serve as the company’s senior safety spokesperson in regulatory inspections, audits, and internal and external meetings.
• Lead the design and continuous improvement of the company’s PV system, ensuring compliance with the FDA, EMA, ICH, and other global health authorities.
• Contribute to and ensure timely submission of expedited safety reports, PBRERs, and DSURs.
• Oversee the pharmacovigilance quality management system ensuring full compliance with global safety regulations and internal SOPs.
• Support labelling decisions, safety-related communications, and benefit-risk assessments for regulatory filings.
• Develop and maintain comprehensive PV agreements and ensure compliance with the requirements of the agreements.
• Contribute to the development of company documents including but not limited to IBs, SOPs, protocols, informed consents, clinical study reports, product labels, risk management plans, and safety plans.
• Mentor and develop the drug safety and pharmacovigilance team, fostering a culture of continuous learning and operational excellence.
• Oversee the QPPV and PSMF development and maintenance.
• Develop and manage the PV budgets and staffing projections, ensuring alignment with corporate objectives.
• Other duties as assigned.

Qualifications

• Medical Doctor (MD) or equivalent with at least three (3) years of clinical experience.
• Ten plus (10+) years of progressive experience in pharmacovigilance or drug safety within the pharmacovigilance or biotechnology industry.
• At least five (5) years in senior leadership roles with a proven ability to manage large global teams.
• Deep knowledge of U.S. FDA regulations, ICH guidelines, EU GVP modules, and global PV legislation.
• Demonstrated success in regulatory agency interactions, inspections and health authority negotiations.
• Commercial launch experience required.
• Strategic thinker with strong leadership presence and excellent communication skills.
• Expertise in benefit-risk assessment, signal detection methodologies, and risk management planning.
• Strong decision-making ability under complex and time-sensitive circumstances.
• Proven track record in building and scaling-up global PV systems.
• Executive presence and credibility with regulators, internal boards, and external stakeholders.
• Commitment to patient safety and scientific rigor.
• Innovative mindset, embracing technology and new methodologies in pharmacovigilance.
• Excellent written and verbal communication and presentation skills, with ability to influence and build credibility at all levels of the organization.
• Attention to detail and ability to manage multiple processes and documentation requirements.
• Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint.
• Experience with Oracle Argus or similar commercial safety database required.
• Demonstrated independent and sound decision-making skills; ability to think critically, make decisions in a fast-paced environment, and being accountable for department performance and successful outcomes.
• Must be a self-starter and willing to play a hands-on role in developing the company’s PV function.
• Maintain a positive, approachable and professional attitude.