Director, GPS CERM Medical Review

This role will assist in leading a team of physicians responsible for the medical evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process.

The primary responsibility for this role is to ensure high quality medical assessment and oversight of individual case safety reports medical review process for all case level data and aggregate safety data across the Regeneron product portfolio as well as ensuring adherence to quality and compliance metrics.

The role requires a strong understanding of applicable global regulations and the ability to lead and execute effectively functionally within Regeneron, as well as with vendors and licensing partners externally.

A typical day in this role might include…..

• Responsible for ensuring that assigned staff are appropriately prepared to support current and anticipated activities for medical review and assessment of reports from global development programs and globally marketed products.
• Responsible for ensuring inspection readiness and monitoring quality of the medical aspects of PV deliverables. Incumbent may have a supportive role in audits and health authority inspections.
• With oversight from Head of CERM, responsible for providing oversight to CRO individual case medical reviewers, including internal resources as well as external medical reviewers.
• Leadership and personnel management of the medical review team in accordance with corporate management standards and policies
• Provides direction and guidance to all medical review physician resources, ensuring the highest level of case quality and global regulatory compliance.
• Oversee and ensure the timely review of safety data, both at individual case level and submission of expedited safety reports and other external submissions through effective processes, systems, and internal staff and vendor management
• Support standardization and quality across the ICSR medical review process
• Act as subject matter expert for a team of physicians supporting the ICSR medical review process --Assesses need for process improvement processes, procedures, and solutions to improve medical case quality and works with senior leadership for implementation
• Contribute to study management oversight activities to improve the quality and content of medical safety data such as but not limited to queries, investigator site training, support for investigator-initiated studies (IIS), market research programs (MRPs) and patient support programs (PSPs).
• Ensure inspection-readiness planning and documentation relating to activities in scope of the function
• Provide medical advice and input to the activities of adverse event (AE) case management, including medical review of ICSRs (narrative, coding, labeling, causality, company comment) as well as work closely with GPS teams, leads, and clinical development leads to provide a cohesive, comprehensive, and accurate medical assessment/review of individual case reports

This role might be for you if…

• Ability to apply and provide critical analysis of relevant clinical information for both clinical trial and post-marketing SAE and AESIs. Function as a medical review expert internal and external to GPS for Regeneron compounds.
• Ability to utilize global safety database for purposes of medical case review and queries.
• Ability to effectively communicate (verbal and written) medical rationale and defend medical assessments
• At least 1-year supervisory experience managing direct reports or in a matrix organization with proven proficiency in organizational and planning capabilities preferred
• Strong clinical acumen with expertise in individual case reviews. Ability to manage external vendors and liase with Regeneron clinical and risk management team.
• Knowledge of relevant global guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Minimum of a Doctorate of Medicine
• Clinical experience (may include residency and fellowship training), with 5 + years of industry experience in pharmacovigilance/ drug safety including significant previous experience in medical review of individual cases.