Medical Director, Pharmacovigilance

Stoke Therapeutics•Bedford, MA

1d•$279,000 - $332,000•Hybrid

About The Position

The Medical Director, Pharmacovigilance will be responsible for the medical review of adverse event data, the development of company causality assessment frameworks in post-marketing surveillance, and leading signal detection and management activities. This individual will work in close partnership with PV operations to build rigorous, scalable, medical safety practices suited to a clinical development and complex postmarketing environment. This position will report into the Head of Pharmacovigilance. This is a role for a physician who is energized by developing business practice frameworks and review processes that a growing medical safety function requires and leading the medical safety domain within the organization. Rare disease carries meaningful responsibility to patient and families with limited therapeutic options, and the ideal candidate is a safety physician for whom that responsibility is a genuine source of motivation.

Requirements

MD or equivalent medical degree; clinical training in neurology, pediatric neurology, pediatrics is preferred but not required
Minimum of 5 years of industry pharmacovigilance experience
Experience in post marketing drug safety with exposure to operational and medical complexity of commercial stage AE management and signal detection
Experience in signal detection and management including application of clinical judgement to signal interpretation

Nice To Haves

Contribution to aggregate safety reports including NDA or MAA safety content preferred
Demonstrated ability to work collaboratively within a structure in which leadership in both medical safety and PV operations contribute complementary expertise in building the PV organization

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 ICSR
Oversee appropriate MedDRA coding of postmarketing ICSRs and lead the development of product-specific coding guidelines
Signal Detection – Safety Governance
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 protocol safety sections, informed consent documents, and investigator brochure safety content
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