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.
- Provide oversight of Insmed PV Safety operations and or designated CROs and Vendors, as assigned by the Head of Pharmacovigilance.
- Maintain Quality metrics for PV CROs or Vendors.
- Perform the source document Quality Check (QC) review of adverse eventreports.
- Responsible and oversight for PV inspection readiness activities and quality in collaboration to Insmed Quality Assurance.
- Review and or Author high quality aggregate safety reports including DSUR, PBRER or PADER to meet regulatory and internal deadlines.
- Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
- Critically draft or review documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors.
- Participate in review of scientific literature and create literature summary sections.
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
- Assist designated safety vendors with opinion on obtaining follow-up information for individual cases and ensuring appropriate feedback from Global Clinical and Safety Leads.
- Interface with other Insmed functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
- Contribute to on-going process enhancement for safety operations such as developing standard procedures and templates.
• 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.