Director, Pharmacovigilance / Product Safety

About the role

We're seeking a Director, Pharmacovigilance / Product Safety to join our Drug Safety & Pharmacovigilance team. This role involves 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, managing ongoing and cross-functional assessments of benefit-risk profiles and related actions.
• Develop and manage a comprehensive risk management system for risk detection, assessment, and 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).
• Support the development and management of REMS for assigned products.
• Ensure compliance 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 and 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.
• A knowledge and understanding of national & international PV and regulatory guidelines.
• Knowledge of Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Qualifications

• Experience with drug safety database knowledge is preferred.
• Experience presenting drug safety topics for regulatory authorities at conventions, meetings, etc.
• Experience in product defense before a national or international regulatory authority is a plus.

Benefits

Insmed offers a comprehensive benefits package including:

• 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
• Carryer 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

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected.

Pay

$247,000.00 - $337,000.00 Annual