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Director, Pharmacovigilance Operations
Location
United States
Posted
79 days ago
Salary
$220K - $270K / year
Seniority
Lead
Job Description
Director, Pharmacovigilance Operations
Celcuity
• 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.
Job Requirements
- 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.
Benefits
- Annual performance incentive bonus
- New hire equity package
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- Paid time off
- Paid holidays
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