Director, Pharmacovigilance / Product Safety

Insmed Incorporated•NJ Corporate Headquarters, NJ

6d•$247,000 - $337,000•Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a 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 be the DSPV expert for assigned products; maintaining current knowledge of assigned product portfolio and safety profiles for products. You will be responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.

Requirements

MD or DO
2 years of Clinical Patient Care experience
5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products
3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.
The ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information
Knowledge and understanding of national & international PV and regulatory guidelines
Ability to present drug safety topics for regulatory authorities at conventions, meetings, etc.
Drug safety database knowledge preferred
Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills

Nice To Haves

Product defense before a national or international regulatory authority a plus

Responsibilities

Review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds.
Conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information.
Leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents such as Safety Signal Assessment Reports for assigned products and development compounds.
Lead the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for assigned products.
Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
Work with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
Direct and collaborate on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed for assigned products.
Ensure Risk Management System, Risk Management Plans (RMPs) for marketed and developmental products and Risk Minimization Measures (RMMs) are compliant with US, EU and International regulations and standards including ICH and EU GVP.
Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports.
Share DSPV and medical expertise on assigned products with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Medical Information, Marketing, Manufacturing, and Legal.
Provide expert safety input to the clinical development program for assigned products and development compound.

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