Manager, DSPV Safety Scientist

Insmed Incorporated

3d • Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Manager, Safety Scientist to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, DSPV Gene Therapy Safety Lead, the Manager, Safety Scientist contributes to DSPV Medical Safety activities across assigned products. The Manager will communicate with designated vendors and CROs, manage signal detection meetings, participate in regulatory inspections, and review and report out individual and aggregate safety data from multiple sources to support regulatory submissions and aggregate reporting requirements.

Requirements

• Bachelor’s degree in the life sciences, pharmacy, nursing, or other health care related field and 5+ years of experience in Drug Safety/Pharmacovigilance within a pharmaceutical industry setting across both investigational and marketed products.
• 4+ years of experience with medical case reviews, aggregate safety reporting, safety surveillance, signal management, and/or risk management.
• Proven experience with end-to-end project management in Drug Safety/PV.
• In-depth knowledge of medical terminology, GCP & ICH guidelines, global drug safety and drug development processes, and current US and international pharmacovigilance regulations.
• Ability to review and or prepare scientific or regulatory documents from large volumes of scientific information.
• Impeccable communication skills, both verbal and written.
• Excellent organizational skills with a strong attention to detail, clarity, accuracy, and conciseness.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Nice To Haves

• Advanced degree (Masters, PharmD, PhD) preferred.
• Master of Public Health (MPH), Master of Health Administration (MHA), or an MBA is a plus.
• Drug safety database knowledge preferred.
• Active participation in regulatory inspections is a plus.

Responsibilities

• Support the Medical Safety Lead in the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches.
• Author, review, and support the preparation for high quality aggregate safety reports including DSUR, PBRER, PADER, SUSAR, and Line Listing Reports to meet internal deadlines and regulatory timelines.
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
• Draft and/or review critical documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency; facilitate document review by other contributors.
• Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, and signal evaluations).
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas and prepare for signal detection activities including data collection, review, and analysis of data.
• Assist designated safety vendors with acquiring follow-up information for individual cases and ensure appropriate feedback from Global Clinical and Safety Leads.
• Participate with and provide oversight of Insmed DSPV Medical Safety and/or designated CROs and Vendors.
• Participate with DSPV inspection readiness activities in collaboration with the Senior Director of Operations Standards and Training and Insmed Quality Assurance.
• Participate in Clinical Study reconciliation activities for different products and collaborate with Insmed Data Management and vendor, as needed.
• Contribute to and have oversight of documents such as the Safety Management Plan(s), Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees