Director, Pharmacovigilance Operations

Role Summary

We are seeking a Director, Pharmacovigilance Operations who will report to the Executive Director, Drug Safety and Pharmacovigilance. You will lead and oversee the global Pharmacovigilance (PV) operational infrastructure. This role is responsible for the oversight of outsourced safety/pharmacovigilance activities, vendor oversight, and operational compliance across Celcuity’s post-marketing program. The Director will play a pivotal role in scaling PV operational capabilities, ensuring inspection readiness, maintaining regulatory compliance, and contributing to strategic safety planning.

Responsibilities

• Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases.
• Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting.
• Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits.
• Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
• Collaborate with stakeholders to ensure alignment of PV strategy, compliance, and status of the PV system.
• Support development and maintenance of internal PV policies, SOPs, training programs, and the maintenance of the pharmacovigilance system.
• Support safety signal detection activities and participate in safety governance committees.
• Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements.
• Lead the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs).
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes.
• Contribute to the preparation and submission of safety reports including but not limited to RMPs, DSURs, PSUR/PBRER, PADER, and PSMF.
• Develop and author responses to PV-related health authority inquiries and other regulatory communications.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing or related field.
• Minimum of ten (10) years of post-marketing safety experience at a biotech or pharmaceutical company.
• Strong experience managing CRO/vendor relationships, particularly in the post-marketing period.
• Deep understanding PV regulations and reporting requirements (e.g. FDA, EMA, MHRA, etc.).
• Demonstrated ability to lead PV operations ensure compliance and drive continuous improvement in a fast-growing environment.
• Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
• Strong interpersonal skills for interacting with employees and leaders across various levels and functions.
• 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.
• Extensive experience with commercial safety databases such as Oracle Argus or ARISg.
• Ability to work in a team or independently as required.
• Outstanding organizational skills with the ability to prioritize.
• Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
• Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
• Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.