Celcuity · 18 hours ago
Director, Pharmacovigilance Operations
United States
Full-time
Remote
Director/Executive
$220K/yr - $270K/yr
10+ years expCelcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer. They are seeking a Director of Pharmacovigilance Operations to lead the oversight of global pharmacovigilance activities, ensuring compliance and operational readiness for post-marketing programs.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
Hiring Manager
Brenden Watson
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
Qualification
Required
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
Benefits
Medical
Dental
Vision insurance
401(k) match
PTO
Paid holidays
Company
Celcuity
Celcuity is a biotechnology company translating discoveries of new cancer sub-types into expanded therapeutic options for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Innovatus Capital PartnersVenrock Healthcare Capital PartnersBrightstone Venture Capital
2025-09-09Post Ipo Debt· $500M
2025-07-30Post Ipo Equity· $85M
2025-07-30Post Ipo Debt· $175M
Leadership Team
Brian Sullivan
Co-Founder, Chairman, CEO
Eldon Mayer
Chief Commercial Officer (CCO)
Recent News
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