Associate Director, Pharmacovigilance/ Product Safety
About the role
We're seeking an Associate Director, Pharmacovigilance/ Product Safety to join our Drug Safety & Pharmacovigilance team. Reporting to the Executive Director, DSPV Medical Safety, you'll provide medical expertise regarding the safety and risk assessment of Insmed products throughout their lifecycle.
Responsibilities
- Provide medical significance and expectedness assessment of AE/SAE reports and case narratives.
- Compile analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses.
- Contribute to safety sections of safety and non-safety documents.
- Author, review, and approve drug-safety related regulatory reports and clinical study documents.
- Interact with drug safety vendors for medical review and safety assessment activities.
- Participate in internal safety review committee meetings.
Requirements
- Masters degree in life sciences, RN, PharmD, or MD with 3-5 years of experience in safety officer or similar roles.
- Experience in device areas is preferred.
- Expertise in pharmacovigilance regulations and industry standards.
- Strong leadership and communication skills.
- Organized with a strong attention to detail.
Qualifications
- Medical or nursing background.
- PharmD or MD.
- Minimum 3-5 years of experience in pharmacovigilance or similar roles.
Skills
- Management of safety information from clinical development and post-marketing sources.
- Knowledge of MedDRAs and industry-standard pharmacovigilance databases.
- Ability to conduct benefit-risk assessments and prepare regulatory reports.
- Experience with safety reporting systems and post-market surveillance.
Benefits
Insmed offers comprehensive benefits including medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide a 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
Pay
$179,000.00 - $232,500.00 Annual
Schedule
This is a fully remote role. Occasional travel for team meetings or events is expected. Travel requirements are minimal, up to 10% annually.