Senior Director, Pharmacovigilance, Drug Safety

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• direct the operational delivery of clinical trial safety services • ensure all active clinical trials meet client-specific Service Level Agreements (SLAs) • oversee the timely preparation and distribution of Investigator Letters and expedited safety reports • lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure • formulate the roadmap to expand post-marketing services globally • author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs) • establish operational workflows for global literature screening and localized digital media safety monitoring • ensure compliance with expedited reporting timelines

🎯 Requirements

• PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline • minimum 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical setting • at least 5 years in a CRO leadership role • demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing • profound understanding of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules • proven experience building, scaling, or launching a new functional capability or service line within a life sciences organization • deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • a pension plan • generous paid time off and sick leave • opportunity to earn a performance based bonus