Corporate Director of Pharmacovigilance

Carlsbad, California | Full-Time

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The incumbent will provide medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events. The role will operationalize strategic priorities, safety governance process improvements, and operating procedures to ensure compliance with appropriate regulations and quality standards for drugs for pre-approval and post-marketing. Line management and responsibility for managing a busy team in the global Pharmacovigilance department which covers the drug safety surveillance, signal detection, safety evaluation, and safety management to ensure in compliance with company’s operating procedures, regulatory requirements.



  • Plans, designs and executes all US pharmacovigilance activities and systems related to enable US launch of product and post marketing.
  • Manages on-going product safety in support of the safety governance process.
  • Provides leadership oversight and responsibility for processing ICSR, provides medical review for ICSR. 
  • Participates in Safety Management Team (SMT) and Company Safety Board (CSB) activities. Chairs SMTs for assigned global products. Provides leadership in managing on-going safety surveillance, signal detection, risk assessment, risk evaluation and risk management.
  • Provides/implements proactive safety analysis strategies to further define the product safety profile.
  • Authors or contributes to safety sections of clinical investigator brochures, risk profiles, protocols, labels and regulatory reports (e.g. PSUR, DSUR, PADER, Annual IND report; 6-monthly line-listings) with focus on providing overview for the medical analysis and safety sections.
  • Provides expert level consultation on safety risk management, signal detection, and epidemiological issues to a variety of stakeholders across GWP programs.
  • Authors or contributes to Safety sections of NDA/MAAs and other regulatory submissions (e.g., integrated summary of safety, and/or summary of clinical safety, PSMF, RMP, etc.).
  • Ensures compliance with US and international pharmacovigilance regulations.
  • Participates/leads in vendor selection and vendor management.
  • Working closely with the global head of PV, serves as a lead representative in organizing and communicating with Regulatory authorities on safety matters.
  • Participates in multidisciplinary teams to assess new product opportunities and develop clinical research strategy to include the evaluation of product safety.
  • Coordinates with Corporate Compliance to provide relevant cross-function pharmacovigilance training.



  • MD and a minimum of 8 years of experience in pharmacovigilance gained in pharmaceutical industry, coupled with 2-3 years of management experience in Pharmacovigilance or Drug Safety.
  • In depth clinical and pharmaco-epidemiologic experience.
  • Strategic proficiency in crafting approach to relevant FDA, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICHGCP/CIOMS best practices).
  • Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.
  • Proficiency with safety databases and safety coding dictionaries (e.g., MedDRA, WHODRUG).
  • Critical thinking and analytical skills and ability to make high-level decisions.
  • Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters with faculty and staff.
  • Excellent communication and collaboration skills with the ability to present to internal/external groups, and establish and maintain good working relationships with a diverse population encompassing multi-disciplinary researchers, faculty and staff about complex research issues.
  • Detail-oriented, with good organizational, prioritization, communication, and time management proficiencies.
Greenwich Biosciences / GW Pharmaceuticals
Greenwich Biosciences / GW Pharmaceuticals
HQ: Carlsbad, California

GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.

Company size: 900

  • Salary
  • Career Level
  • Degree
  • Experience
  • Job Type
  • Attractive
  • Director
  • Master's Degree
  • 7-10 Years
  • Full-Time
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