Sr. Medical Director, Pharmacovigilance

Key Responsibilities

• Medical Case Review: Lead medical review of individual case safety reports (ICSR), including serious adverse events (SAE) and adverse events of clinical interest (AECI) across clinical and postmarketing settings; oversee medical review of ICSR performed by vendors/contractors.
• Develop and implement a company causality framework for clinical trial and postmarketing AE data.
• Build and oversee business practices and review workflows that support consistent and inspection-ready medical assessment of ICSRs.
• Oversee appropriate MedDRA coding of postmarketing ICSRs and lead the development of product-specific coding guidelines.
• Lead signal detection and management activities including development/maintenance of product-specific signal detection plans.
• Develop and refine signal detection methodologies appropriate to the postmarketing environment including consideration of data sources, disproportionality analysis.
• Prepare and present signal assessments to the Head of PV and applicable safety governance bodies, with clear benefit-risk contextualization.
• Maintain signal tracking and disposition process ensuring signals are documented, evaluated and closed or escalated in accordance with company procedures and regulatory expectations.
• Serve as the chair of the cross-functional, internal safety review committee (ISRC) responsible for analysis of validated safety signals and for development of recommendations on risk classification and risk mitigation actions to the Stoke Executive Safety Committee (ESC).
• Regulatory and Aggregate Safety: Contribute medical safety content to aggregate safety reports (DSUR, PSUR, PBRER) and NDA/MAA safety summaries with particular responsibility for medical narrative sections and clinical interpretation of safety findings.
• Provide medical input into Company Core Safety Information and safety content of country-specific product labeling.
• Support regulatory agency interactions on medical safety matters.
• Contribute to development and maintenance of reference safety information.

Organizational Development

• Collaborate with the Head of Pharmacovigilance and PV Operational leadership on PV departmental capability building, PV System building, developing medical strategies, contributing medical expertise to PV procedures, vendor oversight and safety database governance as it relates to medical review processes.
• Support the development of medical safety staffing requirements and contribute to hiring and onboarding medical safety personnel as the function grows.
• Represent medical safety with clarity and credibility to internal stakeholders across clinical development, medical affairs, regulatory affairs and commercial functions.