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.
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
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