Associate Director, Pharmacovigilance/ Product Safety
About The Position
We’re looking for an Associate Director, Pharmacovigilance/ Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you’ll provide medical expertise regarding the safety and risk assessment of Insmed products at all stages of the product life cycle (clinical to post-marketing). This individual will ensure that the safety data are evaluated medically and put in context thus underpinning risk management initiatives. This individual will have responsibility for medical assessment and medical review activities and may contribute to safety sections of safety and non-safety documents.
Requirements
- Masters degree in life sciences, an RN, PharmD or MD
- 3-5 years minimum experience in the role of safety officer or similar pharmacovigilance leadership role in the pharmaceutical industry.
- Strong skills in the management of safety information originating from both clinical development and post-marketing sources.
- Expert knowledge of the regulations governing pharmacovigilance.
- Working knowledge of industry standard pharmacovigilance databases and MedDRA.
- Strong Leadership skills and ability to communicate with individuals at all levels (administrative to key thought leaders).
- Excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
Nice To Haves
- Device experience strongly preferred
Responsibilities
- Provide medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives prepared by vendors or Insmed.
- Compile analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy.
- Provide medical input for maintaining RMP and post-marketing safety monitoring commitments.
- Provide periodic benefit-risk assessment reports for internal use.
- Investigate and review emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources.
- Author, review and provide input and approval for drug-safety related regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package and labeling.
- Interacts with drug safety vendor for medical review and safety assessment activities.
- Be an active member in internal safety review committee meetings.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- annual wellbeing reimbursement
- access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- fertility and family-forming benefits
- caregiver support
- flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- annual equity awards
- participation in our Employee Stock Purchase Plan (ESPP)
- company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- service and recognition programs
- meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
