Associate Director, Pharmacovigilance/Product Safety
Insmed Incorporated
Summary
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.
Job description
What You'll Do
In this role, you'll have the opportunity to provide medical significance and expectedness assessment of AE/SAE reports and approving AE/SAE case narratives prepared by vendors or Insmed. You'll also:
- 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 source
- 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
Who You Are
You have an MD or equivalent degree and a minimum of 1 year experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry OR 3 years within a clinical care setting. You are or you also have:
- 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 Have (but not required)
- Device experience strongly preferred
- 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
Where You'll Work
This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements
Minimal travel expected - up to 10% annually
Requirements
- MD or equivalent degree
- Minimum of 1 year experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry OR 3 years within a clinical care setting
- Strong Leadership skills and ability to communicate with individuals at all levels
- Excellent communication skills (verbal and written)
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness
Benefits
- Medical, Dental & Vision
- Mental health support
- Annual wellbeing reimbursement
- Employee Assistance Program
- Paid time off
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules
- 401(k) plan
- Company match
- Annual equity awards
- Employee Stock Purchase Plan
- Life insurance
- Disability insurance
- LinkedIn Learning
- Skill building workshops
- Leadership programs
- Mentorship connections
Company overview
Insmed Incorporated is a people-first global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Headquartered in Bridgewater, New Jersey, with offices and research locations throughout the United States, Europe, and Japan, the company focuses on delivering first- and best-in-class therapies for underserved patient communities. Insmed's portfolio includes two approved therapies for chronic lung diseases: ARIKAYCE for Mycobacterium avium complex lung disease and BRINSUPRI for non-cystic fibrosis bronchiectasis. The company is advancing a diverse pipeline of mid- to late-stage investigational medicines and cutting-edge drug discovery programs spanning gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue technologies. Recognized as the No. 1 Science Top Employer for five consecutive years, Insmed employs 1,001-5,000 professionals globally and maintains a strong commitment to innovation, patient-centricity, and corporate responsibility.