Medical Director Pharmacovigilance, Rare Disease & PDT
Scorpion Therapeutics, New Bremen, Ohio, United States
Role Summary
Medical Director Pharmacovigilance, Rare Disease & PDT — Cambridge, MA — serves as Global Safety Lead and the company-wide patient safety expert for assigned pharmaceutical/biological/drug-device products, accountable for safety strategy and major safety deliverables; leads GPSE Safety Team and Safety Management Team for assigned compounds and represents cross-functional program teams as a product safety profile and risk mitigation expert. Provides medical safety expertise, interprets safety data across non-clinical, clinical, post-marketing and literature sources to assess benefit-risk and update safety documents. Responsibilities
Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned products; lead GPSE Safety Team (GST) and Safety Management Team (SMT); represent the cross-functional program team on safety matters for internal and external stakeholders. Analyze and interpret safety data from various sources (non-clinical, clinical, post-marketing, literature) to assess benefit-risk and update safety documents (e.g., RMPs). Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies, ethics committees, MAAs, NDAs, and BLAs. Provide medical safety expertise, interpretation, review, and authorship of sections for critical documents (protocols, amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, SARs, INDs, NDAs, BLAs, CTAs) in collaboration with cross-functional colleagues. Provide patient safety input to the clinical development program and represent GPSE on internal governance bodies for study protocols, SAPs, and other study-related documents. Collaborate and communicate safety issues with Clinical Development, Regulatory Affairs, QA, Medical Affairs, Marketing, Manufacturing, and Legal; ensure up-to-date safety information in the Company Core Data Sheet and Investigator Brochure, and other labeling documents. Travel up to 10% domestically for internal meetings; full remote work permitted. Qualifications
Required: Doctor of Medicine (M.D.) plus 5 years of related experience. Required: Experience using Oracle Empirica for routine signal detection, analyzing safety data, identifying trends, and detecting new or emerging safety signals from diverse data sources (AERs, clinical trial data, literature). Required: Ability to analyze data with statistical methodologies (e.g., disproportionality analysis) to assess safety concerns and evaluate frequency/severity of adverse events; develop risk management plans and risk minimization strategies. Required: Experience evaluating and developing periodic safety reports (e.g., PSURs, Development Safety Update Reports, periodic adverse drug experience reports); MedDRA terms and WHO-DD coding; medical review of adverse event reports for seriousness, expectedness, and causality. Required: Experience designing and implementing strategic, operational, and personnel development plans and training curricula for Pharmacovigilance teams. Skills
Strong pharmacovigilance and safety data interpretation Signal detection and risk assessment Cross-functional collaboration and stakeholder management Regulatory inquiry response and safety document preparation MedDRA and WHO DD coding; safety data standardization Leadership and training development Education
Doctor of Medicine (M.D.) Additional Requirements
Up to 10% domestic travel for internal meetings Up to 100% remote work permitted
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Medical Director Pharmacovigilance, Rare Disease & PDT — Cambridge, MA — serves as Global Safety Lead and the company-wide patient safety expert for assigned pharmaceutical/biological/drug-device products, accountable for safety strategy and major safety deliverables; leads GPSE Safety Team and Safety Management Team for assigned compounds and represents cross-functional program teams as a product safety profile and risk mitigation expert. Provides medical safety expertise, interprets safety data across non-clinical, clinical, post-marketing and literature sources to assess benefit-risk and update safety documents. Responsibilities
Serve as Global Safety Lead (GSL) and company-wide patient safety expert for assigned products; lead GPSE Safety Team (GST) and Safety Management Team (SMT); represent the cross-functional program team on safety matters for internal and external stakeholders. Analyze and interpret safety data from various sources (non-clinical, clinical, post-marketing, literature) to assess benefit-risk and update safety documents (e.g., RMPs). Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies, ethics committees, MAAs, NDAs, and BLAs. Provide medical safety expertise, interpretation, review, and authorship of sections for critical documents (protocols, amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, SARs, INDs, NDAs, BLAs, CTAs) in collaboration with cross-functional colleagues. Provide patient safety input to the clinical development program and represent GPSE on internal governance bodies for study protocols, SAPs, and other study-related documents. Collaborate and communicate safety issues with Clinical Development, Regulatory Affairs, QA, Medical Affairs, Marketing, Manufacturing, and Legal; ensure up-to-date safety information in the Company Core Data Sheet and Investigator Brochure, and other labeling documents. Travel up to 10% domestically for internal meetings; full remote work permitted. Qualifications
Required: Doctor of Medicine (M.D.) plus 5 years of related experience. Required: Experience using Oracle Empirica for routine signal detection, analyzing safety data, identifying trends, and detecting new or emerging safety signals from diverse data sources (AERs, clinical trial data, literature). Required: Ability to analyze data with statistical methodologies (e.g., disproportionality analysis) to assess safety concerns and evaluate frequency/severity of adverse events; develop risk management plans and risk minimization strategies. Required: Experience evaluating and developing periodic safety reports (e.g., PSURs, Development Safety Update Reports, periodic adverse drug experience reports); MedDRA terms and WHO-DD coding; medical review of adverse event reports for seriousness, expectedness, and causality. Required: Experience designing and implementing strategic, operational, and personnel development plans and training curricula for Pharmacovigilance teams. Skills
Strong pharmacovigilance and safety data interpretation Signal detection and risk assessment Cross-functional collaboration and stakeholder management Regulatory inquiry response and safety document preparation MedDRA and WHO DD coding; safety data standardization Leadership and training development Education
Doctor of Medicine (M.D.) Additional Requirements
Up to 10% domestic travel for internal meetings Up to 100% remote work permitted
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