Medical Director, Pharmacovigilance
Stoke Therapeutics
4 months ago
Remote friendly (Bedford, MA)
United States
Medical Affairs
Position Purpose:
Medical review of adverse event data, development of company causality assessment frameworks in post-marketing surveillance, and leading signal detection and management activities (reports to Head of Pharmacovigilance).
Key Responsibilities:
- Lead medical review of individual case safety reports (ICSRs), including SAEs and AECIs; oversee vendor/contractor medical review.
- Develop and implement company causality framework for clinical trial and postmarketing AE data.
- Build and oversee inspection-ready ICSR review workflows and business practices.
- Oversee MedDRA coding for postmarketing ICSRs and develop product-specific coding guidelines.
- Lead signal detection/management, including product-specific signal detection plans.
- Refine signal detection methodologies (data sources, disproportionality analysis) appropriate to postmarketing.
- Present signal assessments with benefit-risk contextualization; maintain signal tracking/disposition.
- Chair internal safety review committee (ISRC) and recommend risk classification/mitigation to the Executive Safety Committee.
- Contribute medical narrative and clinical interpretation for DSUR/PSUR/PBRER and NDA/MAA safety summaries; provide input to Core Safety Information and labeling.
- Support regulatory agency interactions; contribute to protocols, informed consent, investigator brochure, and reference safety information.
- Collaborate with PV leadership on medical/PV capability building, vendor oversight, and safety database governance; support staffing/hiring and represent medical safety across functions.
Required/Preferred Skills & Experience:
- MD or equivalent; clinical training in neurology/pediatric neurology/pediatrics preferred.
- 5+ years industry pharmacovigilance experience.
- Postmarketing drug safety experience with commercial-stage AE management and signal detection.
- Experience in signal detection/management using clinical judgment; aggregate safety report contribution (NDA/MAA) preferred.
Compensation & Benefits (as stated):
- Anticipated salary: $279,000–$332,000; annual bonus and equity participation.
- Medical/dental/vision; life and disability insurance; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
Apply via Stoke’s Career Center: https://www.stoketherapeutics.com/careers/
Medical review of adverse event data, development of company causality assessment frameworks in post-marketing surveillance, and leading signal detection and management activities (reports to Head of Pharmacovigilance).
Key Responsibilities:
- Lead medical review of individual case safety reports (ICSRs), including SAEs and AECIs; oversee vendor/contractor medical review.
- Develop and implement company causality framework for clinical trial and postmarketing AE data.
- Build and oversee inspection-ready ICSR review workflows and business practices.
- Oversee MedDRA coding for postmarketing ICSRs and develop product-specific coding guidelines.
- Lead signal detection/management, including product-specific signal detection plans.
- Refine signal detection methodologies (data sources, disproportionality analysis) appropriate to postmarketing.
- Present signal assessments with benefit-risk contextualization; maintain signal tracking/disposition.
- Chair internal safety review committee (ISRC) and recommend risk classification/mitigation to the Executive Safety Committee.
- Contribute medical narrative and clinical interpretation for DSUR/PSUR/PBRER and NDA/MAA safety summaries; provide input to Core Safety Information and labeling.
- Support regulatory agency interactions; contribute to protocols, informed consent, investigator brochure, and reference safety information.
- Collaborate with PV leadership on medical/PV capability building, vendor oversight, and safety database governance; support staffing/hiring and represent medical safety across functions.
Required/Preferred Skills & Experience:
- MD or equivalent; clinical training in neurology/pediatric neurology/pediatrics preferred.
- 5+ years industry pharmacovigilance experience.
- Postmarketing drug safety experience with commercial-stage AE management and signal detection.
- Experience in signal detection/management using clinical judgment; aggregate safety report contribution (NDA/MAA) preferred.
Compensation & Benefits (as stated):
- Anticipated salary: $279,000–$332,000; annual bonus and equity participation.
- Medical/dental/vision; life and disability insurance; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
Apply via Stoke’s Career Center: https://www.stoketherapeutics.com/careers/