The Pharmacovigilance (PV) Safety Scientist /Senior Scientist is responsible for participating in the PV operational activities including but not limited to interfacing with designated vendors/CROs, participating in regulatory inspections, individual or aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements and activities pertaining to our products.
This position reports to the Executive Director, Head of Pharmacovigilance, Drug Safety & PV and is located at our Bridgewater, New Jersey headquarters location.
• Bachelors, Master’s or Doctorate level degree in pharmacy, nursing or other health care related profession or life sciences required.
• Additional MPH (Masters of Public Health) or Masters in Business Administration (MBA) or Healthcare Administration is a plus
• Minimum 5 years in Drug safety/Pharmacovigilance in pharmaceutical industry setting with both investigational and marketed products
• Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
• Active participation in regulatory inspections is a plus
• At least 1 years of experience with medical case reviews, aggregate safety reporting, safety surveillance, signal management and/or Risk management
• 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
• Drug safety database knowledge preferred
• Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat computer skills
• Must have excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• May require very occasional Domestic/International as needed (estimated at less than 10% of work time)
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.