Director, Pharmacovigilance / Product Safety

About the role

We're seeking a Director, Pharmacovigilance / Product Safety to join our Drug Safety & Pharmacovigilance team. This role will involve expanding what's possible for patients with serious diseases by maintaining current knowledge of assigned product portfolios and safety profiles.

Responsibilities

• Review all safety data from various sources (pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post-marketing for assigned products and development compounds.
• Conduct safety signal detection activities, monitor, evaluate, interpret, and manage safety information.
• Lead the Safety Review Team(s) for assigned products and development compounds, and manage ongoing and cross-functional assessments 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.
• Develop and manage 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).
• 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 compounds.

Requirements

• An MD or DO 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.
• 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management.

Qualifications

• 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.

Benefits

Insmed offers a range of benefits including comprehensive medical, dental, and vision coverage, 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 are also available. The 401(k) plan includes a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. Additionally, Insmed provides opportunities for professional development through the Employee Learning Institute, 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 are also available.

Pay

$247,000.00 - $337,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected. Travel requirements: Up to 20%.