Director, Pharmacovigilance / Product Safety
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.
What You'll Do
In this role, you’ll have the opportunity to review 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. You’ll also:
- Be responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
- Have 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
Who You Are
You have an MD or DO along with 2 years of Clinical Patient Care experience, 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products and 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management. You are or also have:
- 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.
- Product defense before a national or international regulatory authority a plus
- Drug safety database knowledge preferred
- Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
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.
Pay
$247,000.00 - 337,000.00 Annual
Life at Insmed
At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include:
- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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, and meaningful opportunities to connect, volunteer, and give back