Associate Director, Pharmacovigilance/ Product Safety
Insmed Incorporated
August 20, 2026
Remote
United States
Medical Affairs
Associate Director, Pharmacovigilance / Product Safety (Drug Safety & Pharmacovigilance)
About the Role
- Provide medical expertise for safety and risk assessment of Insmed products across the product lifecycle (clinical to post-marketing).
- Ensure safety data are medically evaluated and contextualized to support risk management initiatives.
- Own medical assessment/review activities; may contribute to safety sections of safety and non-safety documents.
What You’ll Do
- Assess medical significance and expectedness for AE/SAE reports; approve AE/SAE case narratives prepared by vendors or Insmed.
- Compile analyses of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses.
- Provide medical input to maintain RMP and post-marketing safety monitoring commitments.
- Produce periodic internal benefit-risk assessment reports.
- Investigate/review emerging safety data from sources such as clinical trial AE/SAE, spontaneous ADRs, literature, aggregate reports, toxicology, non-clinical studies.
- Author/review/approve regulatory drug-safety reports and clinical study documents (protocols, ICFs, investigator brochures, ISS/ISE, MedDRA coding, product labeling).
- Partner with drug safety vendors for medical review/safety assessment.
- Participate in internal safety review committee meetings.
Who You Are
- Master’s in life sciences, or RN/PharmD/MD.
- 3–5+ years minimum as safety officer or similar pharmacovigilance leadership role in pharma.
You Are Or Also Have
- Device experience strongly preferred.
- Strong safety information management (clinical and post-marketing).
- Expert pharmacovigilance regulations knowledge.
- Working knowledge of pharmacovigilance databases and MedDRA.
- Strong leadership, communication, and organization; high attention to detail.
Work/Travel/Pay
- Fully remote; occasional travel up to 10% annually.
- Pay range: $164,000–$213,000 annually.
Benefits (U.S. offerings)
- Medical/dental/vision, mental health support/EAP; paid time off; 401(k) match; equity awards; ESPP; life/disability insurance; learning and development; employee assistance and resource groups.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
About the Role
- Provide medical expertise for safety and risk assessment of Insmed products across the product lifecycle (clinical to post-marketing).
- Ensure safety data are medically evaluated and contextualized to support risk management initiatives.
- Own medical assessment/review activities; may contribute to safety sections of safety and non-safety documents.
What You’ll Do
- Assess medical significance and expectedness for AE/SAE reports; approve AE/SAE case narratives prepared by vendors or Insmed.
- Compile analyses of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses.
- Provide medical input to maintain RMP and post-marketing safety monitoring commitments.
- Produce periodic internal benefit-risk assessment reports.
- Investigate/review emerging safety data from sources such as clinical trial AE/SAE, spontaneous ADRs, literature, aggregate reports, toxicology, non-clinical studies.
- Author/review/approve regulatory drug-safety reports and clinical study documents (protocols, ICFs, investigator brochures, ISS/ISE, MedDRA coding, product labeling).
- Partner with drug safety vendors for medical review/safety assessment.
- Participate in internal safety review committee meetings.
Who You Are
- Master’s in life sciences, or RN/PharmD/MD.
- 3–5+ years minimum as safety officer or similar pharmacovigilance leadership role in pharma.
You Are Or Also Have
- Device experience strongly preferred.
- Strong safety information management (clinical and post-marketing).
- Expert pharmacovigilance regulations knowledge.
- Working knowledge of pharmacovigilance databases and MedDRA.
- Strong leadership, communication, and organization; high attention to detail.
Work/Travel/Pay
- Fully remote; occasional travel up to 10% annually.
- Pay range: $164,000–$213,000 annually.
Benefits (U.S. offerings)
- Medical/dental/vision, mental health support/EAP; paid time off; 401(k) match; equity awards; ESPP; life/disability insurance; learning and development; employee assistance and resource groups.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.