Director, Pharmacovigilance / Product Safety
Insmed Incorporated
August 20, 2026
Remote
United States
Medical Affairs
Director, Pharmacovigilance / Product Safety (Drug Safety & Pharmacovigilance)
Responsibilities
- Provide safety surveillance, risk management, and risk communication for assigned development and marketed products.
- Conduct medical assessment of individual adverse event reports; generate and review aggregate reports and safety documents, including labeling changes.
- Lead safety signal detection activities; monitor, evaluate, interpret, manage, and communicate safety information.
- Lead Safety Review Team(s); manage cross-functional benefit-risk assessments and actions; write/update benefit-risk documents (e.g., Safety Signal Assessment Reports).
- Develop and manage a comprehensive risk management system (detection, assessment, minimization).
- Provide medical expert safety review input into critical clinical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Support DSPV safety/benefit-risk strategy implementation; direct/collaborate on product-specific REMS development if needed.
- Ensure RMP/RMM compliance with US, EU, and International regulations (including ICH and EU GVP).
- Provide input to and support writing of periodic reports; interpret, review, and approve required reports.
- Share DSPV/medical expertise with global cross-functional partners; provide expert safety input to clinical development programs.
Qualifications
- MD or DO; 2 years clinical patient care experience.
- 5 years in pharmaceutical industry in Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3 years medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.
- Ability to review/prepare scientific/regulatory documents from large information volumes.
- Knowledge of national and international PV and regulatory guidelines.
- Ability to present drug safety topics to regulatory authorities (product defense a plus).
- Drug safety database knowledge preferred.
Skills
- Microsoft Word, Excel, PowerPoint, Outlook; Adobe Acrobat.
Work/Travel
- Fully remote; occasional travel up to 20%.
Pay Range
- $247,000.00–$337,000.00 annual.
Application instructions
- Applications accepted for 5 calendar days from the posted date or until filled.
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities
- Provide safety surveillance, risk management, and risk communication for assigned development and marketed products.
- Conduct medical assessment of individual adverse event reports; generate and review aggregate reports and safety documents, including labeling changes.
- Lead safety signal detection activities; monitor, evaluate, interpret, manage, and communicate safety information.
- Lead Safety Review Team(s); manage cross-functional benefit-risk assessments and actions; write/update benefit-risk documents (e.g., Safety Signal Assessment Reports).
- Develop and manage a comprehensive risk management system (detection, assessment, minimization).
- Provide medical expert safety review input into critical clinical development documents (protocols/amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
- Support DSPV safety/benefit-risk strategy implementation; direct/collaborate on product-specific REMS development if needed.
- Ensure RMP/RMM compliance with US, EU, and International regulations (including ICH and EU GVP).
- Provide input to and support writing of periodic reports; interpret, review, and approve required reports.
- Share DSPV/medical expertise with global cross-functional partners; provide expert safety input to clinical development programs.
Qualifications
- MD or DO; 2 years clinical patient care experience.
- 5 years in pharmaceutical industry in Drug Safety/Pharmacovigilance (investigational and marketed products).
- 3 years medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.
- Ability to review/prepare scientific/regulatory documents from large information volumes.
- Knowledge of national and international PV and regulatory guidelines.
- Ability to present drug safety topics to regulatory authorities (product defense a plus).
- Drug safety database knowledge preferred.
Skills
- Microsoft Word, Excel, PowerPoint, Outlook; Adobe Acrobat.
Work/Travel
- Fully remote; occasional travel up to 20%.
Pay Range
- $247,000.00–$337,000.00 annual.
Application instructions
- Applications accepted for 5 calendar days from the posted date or until filled.
- Current Insmed employees: apply via the Jobs Hub in Workday.