Manager, DSPV Safety Scientist
Insmed Incorporated
4 months ago
Remote
United States
Operations
Manager, Safety Scientist
About the Role
- Reports to the Senior Director, DSPV Gene Therapy Safety Lead, and contributes to DSPV Medical Safety activities across assigned products.
- Communicates with designated vendors and CROs; manages signal detection meetings; participates in regulatory inspections; reviews and reports individual and aggregate safety data to support regulatory submissions and aggregate reporting requirements.
Responsibilities
- Support the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches.
- Author, review, and support preparation of aggregate safety reports: DSUR, PBRER, PADER, SUSAR, and Line Listing Reports.
- Ensure safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
- Draft and/or review critical documents for regulatory agency safety inquiries (scientific content, alignment, clarity, accuracy, consistency) and facilitate document review by other contributors.
- Review scientific/medical publications for safety information; summarize and critically appraise findings for safety reports (e.g., periodic safety update reports, signal detection reports, signal evaluations).
- Participate in ongoing safety data review and analysis for designated therapeutic areas; prepare for signal detection activities (data collection, review, and analysis).
- Assist safety vendors with follow-up information for individual cases and ensure appropriate feedback from Global Clinical and Safety Leads.
- Provide oversight of Insmed DSPV Medical Safety and/or designated CROs and vendors.
- Participate in DSPV inspection readiness activities with Operations Standards and Training and Insmed Quality Assurance.
- Participate in Clinical Study reconciliation activities; collaborate with Insmed Data Management and vendors as needed.
- Contribute to and provide oversight of Safety Management Plan(s), Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc.
Qualifications (Required)
- Bachelor’s degree in life sciences, pharmacy, nursing, or other health care-related field.
- 5+ years of Drug Safety/Pharmacovigilance experience in a pharmaceutical industry setting across both investigational and marketed products.
Skills/Experience (Required)
- 4+ years in medical case reviews, aggregate safety reporting, safety surveillance, signal management, and/or risk management.
- End-to-end project management experience in Drug Safety/PV.
- In-depth knowledge of medical terminology; GCP & ICH guidelines; global drug safety and drug development processes; current US and international pharmacovigilance regulations.
- Ability to review and/or prepare scientific and regulatory documents from large volumes of information.
- Impeccable verbal and written communication.
- Strong organizational skills and attention to detail, clarity, accuracy, and conciseness.
- Ability to work effectively in a dynamic, culturally diverse workplace.
Nice to Have
- Advanced degree (Master’s, PharmD, PhD).
- MPH, MHA, or MBA.
- Drug safety database knowledge.
- Active participation in regulatory inspections.
Work Location & Travel
- Fully remote.
- Occasional domestic travel up to 10%.
Benefits (explicitly stated)
- $133,000.00–173,000.00 annual pay range.
- Comprehensive medical, dental, vision, mental health support, annual wellbeing reimbursement, and access to EAP.
- Paid time off; fertility and family-forming benefits; caregiver support; flexible schedules.
- 401(k) with competitive match; annual equity awards; participation in ESPP; company-paid life and disability insurance.
- Company Learning Institute (LinkedIn Learning, workshops, leadership programs, mentorship, networking).
- Employee resource groups and service/recognition programs.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
About the Role
- Reports to the Senior Director, DSPV Gene Therapy Safety Lead, and contributes to DSPV Medical Safety activities across assigned products.
- Communicates with designated vendors and CROs; manages signal detection meetings; participates in regulatory inspections; reviews and reports individual and aggregate safety data to support regulatory submissions and aggregate reporting requirements.
Responsibilities
- Support the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches.
- Author, review, and support preparation of aggregate safety reports: DSUR, PBRER, PADER, SUSAR, and Line Listing Reports.
- Ensure safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
- Draft and/or review critical documents for regulatory agency safety inquiries (scientific content, alignment, clarity, accuracy, consistency) and facilitate document review by other contributors.
- Review scientific/medical publications for safety information; summarize and critically appraise findings for safety reports (e.g., periodic safety update reports, signal detection reports, signal evaluations).
- Participate in ongoing safety data review and analysis for designated therapeutic areas; prepare for signal detection activities (data collection, review, and analysis).
- Assist safety vendors with follow-up information for individual cases and ensure appropriate feedback from Global Clinical and Safety Leads.
- Provide oversight of Insmed DSPV Medical Safety and/or designated CROs and vendors.
- Participate in DSPV inspection readiness activities with Operations Standards and Training and Insmed Quality Assurance.
- Participate in Clinical Study reconciliation activities; collaborate with Insmed Data Management and vendors as needed.
- Contribute to and provide oversight of Safety Management Plan(s), Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc.
Qualifications (Required)
- Bachelor’s degree in life sciences, pharmacy, nursing, or other health care-related field.
- 5+ years of Drug Safety/Pharmacovigilance experience in a pharmaceutical industry setting across both investigational and marketed products.
Skills/Experience (Required)
- 4+ years in medical case reviews, aggregate safety reporting, safety surveillance, signal management, and/or risk management.
- End-to-end project management experience in Drug Safety/PV.
- In-depth knowledge of medical terminology; GCP & ICH guidelines; global drug safety and drug development processes; current US and international pharmacovigilance regulations.
- Ability to review and/or prepare scientific and regulatory documents from large volumes of information.
- Impeccable verbal and written communication.
- Strong organizational skills and attention to detail, clarity, accuracy, and conciseness.
- Ability to work effectively in a dynamic, culturally diverse workplace.
Nice to Have
- Advanced degree (Master’s, PharmD, PhD).
- MPH, MHA, or MBA.
- Drug safety database knowledge.
- Active participation in regulatory inspections.
Work Location & Travel
- Fully remote.
- Occasional domestic travel up to 10%.
Benefits (explicitly stated)
- $133,000.00–173,000.00 annual pay range.
- Comprehensive medical, dental, vision, mental health support, annual wellbeing reimbursement, and access to EAP.
- Paid time off; fertility and family-forming benefits; caregiver support; flexible schedules.
- 401(k) with competitive match; annual equity awards; participation in ESPP; company-paid life and disability insurance.
- Company Learning Institute (LinkedIn Learning, workshops, leadership programs, mentorship, networking).
- Employee resource groups and service/recognition programs.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.