Director, Medical Safety Lead - DSPV, Gene Therapy
Insmed Incorporated
4 months ago
Remote
United States
Medical Affairs
Director, Medical Safety Lead - DSPV Gene Therapy
About the Role
- Serve as DSPV subject matter expert for assigned products, maintaining deep, up-to-date knowledge of the product portfolio and associated safety profiles.
- Responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products.
- Perform medical evaluation of individual adverse event reports; oversee aggregate report generation and safety documentation; collaborate on labeling updates.
- Provide expert DSPV support to internal and external stakeholders.
What You'll Do
- Review safety data from pre-clinical, clinical, post-marketing, and literature sources throughout development and post marketing for assigned products and development compounds.
- Conduct safety signal detection, monitoring, evaluation, interpretation, and appropriate management/communication of safety information.
- Lead Safety Review Team(s); manage cross-functional benefit-risk assessment and related actions, including writing/updating benefit-risk documents.
- Provide medical expert safety input into critical clinical development documents (e.g., protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Develop and implement safety and benefit-risk management strategy; develop key content of Risk Management documents (RMPs, REMS).
- Provide input into periodic reports; provide medical interpretation, review, and approval for required reports.
- Share DSPV/medical expertise with global cross-functional teams (Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, Legal).
- Ensure accurate representation/communication of safety profiles with Regulatory Affairs labeling team.
- Provide integrated safety input to regulatory documents; assess safety profiles for Due Diligence projects; provide drug safety input for product recalls, Health Hazard Evaluations, and Dear Healthcare Professional letters.
- Respond to regulatory authority inquiries on safety issues.
Who You Are (Qualifications)
- MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance in the pharmaceutical industry across investigational and marketed products.
Required Skills/Experience
- Experience reviewing/preparing scientific or regulatory documents from large volumes of information.
- Knowledge of national and international pharmacovigilance and regulatory guidelines.
- Experience presenting drug safety topics to regulatory authorities and at conventions/meetings.
- Impeccable verbal and written communication skills.
- Excellent organizational skills and strong attention to detail (clarity, accuracy, conciseness).
- Demonstrated ability to work effectively in a dynamic, culturally diverse workplace.
Nice to Have
- MPH.
- 2+ years clinical patient care experience.
- Drug safety database knowledge.
- Gene therapy product experience.
- Product defense before national/international regulatory authorities.
Work Location / Travel
- Fully remote; occasional domestic travel up to 20%.
Application Instructions
- Applications are accepted for 5 calendar days from the date posted or until the position is filled.
About the Role
- Serve as DSPV subject matter expert for assigned products, maintaining deep, up-to-date knowledge of the product portfolio and associated safety profiles.
- Responsible for safety surveillance, risk management, and risk communication across assigned development and marketed products.
- Perform medical evaluation of individual adverse event reports; oversee aggregate report generation and safety documentation; collaborate on labeling updates.
- Provide expert DSPV support to internal and external stakeholders.
What You'll Do
- Review safety data from pre-clinical, clinical, post-marketing, and literature sources throughout development and post marketing for assigned products and development compounds.
- Conduct safety signal detection, monitoring, evaluation, interpretation, and appropriate management/communication of safety information.
- Lead Safety Review Team(s); manage cross-functional benefit-risk assessment and related actions, including writing/updating benefit-risk documents.
- Provide medical expert safety input into critical clinical development documents (e.g., protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Develop and implement safety and benefit-risk management strategy; develop key content of Risk Management documents (RMPs, REMS).
- Provide input into periodic reports; provide medical interpretation, review, and approval for required reports.
- Share DSPV/medical expertise with global cross-functional teams (Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, Legal).
- Ensure accurate representation/communication of safety profiles with Regulatory Affairs labeling team.
- Provide integrated safety input to regulatory documents; assess safety profiles for Due Diligence projects; provide drug safety input for product recalls, Health Hazard Evaluations, and Dear Healthcare Professional letters.
- Respond to regulatory authority inquiries on safety issues.
Who You Are (Qualifications)
- MD or DO with 5+ years of experience in Drug Safety/Pharmacovigilance in the pharmaceutical industry across investigational and marketed products.
Required Skills/Experience
- Experience reviewing/preparing scientific or regulatory documents from large volumes of information.
- Knowledge of national and international pharmacovigilance and regulatory guidelines.
- Experience presenting drug safety topics to regulatory authorities and at conventions/meetings.
- Impeccable verbal and written communication skills.
- Excellent organizational skills and strong attention to detail (clarity, accuracy, conciseness).
- Demonstrated ability to work effectively in a dynamic, culturally diverse workplace.
Nice to Have
- MPH.
- 2+ years clinical patient care experience.
- Drug safety database knowledge.
- Gene therapy product experience.
- Product defense before national/international regulatory authorities.
Work Location / Travel
- Fully remote; occasional domestic travel up to 20%.
Application Instructions
- Applications are accepted for 5 calendar days from the date posted or until the position is filled.