Director, Pharmacovigilance / Product Safety
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Insmed Inc. is hiring a Director, Pharmacovigilance / Product Safety. The Director, Pharmacovigilance / Product Safety will lead safety surveillance, risk management, and risk communication for assigned products, providing medical expert input on safety documents and collaborating with global functional teams to ensure compliance with regulatory standards.
Key focus areas include Review safety data from pre‑clinical, clinical, post‑marketing and literature sources throughout development and post‑marketing phases, Conduct safety signal detection, monitoring, evaluation, interpretation and management of safety information, and Lead Safety Review Teams and manage benefit‑risk assessments and related documentation.
Important skills include Safety Signal Detection, Risk Management, Risk Communication, Medical Expert Safety Review, Regulatory Document Preparation, and ICH Guidelines Knowledge. Preferred (not required): Drug Safety Database Knowledge.
Skills & qualifications
Skills
Qualifications
Benefits
Full job description
Compensation
$247,000.00 - $247,000.00 / Yearly
Hours Per Week
40
Number Of Positions
1
Job Description
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 Director, Pharmacovigilance / Product Safety on the Drug Safety & Pharmacovigilance team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, DSPV Medical Safety, you'll be the DSPV expert for assigned products; maintaining current knowledge of assigned product portfolio and safety profiles for products.
You will be responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.
What You'll Do:
In this role, you'll have the opportunity to review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds. You'll also:
Be responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
Have leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents such as Safety Signal Assessment Reports for assigned products and development compounds
Lead the development and management of a comprehensive risk management system for risk detection, risk assessment and risk 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).
Work with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
Direct and collaborate on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed for assigned products.
Ensure Risk Management System, Risk Management Plans (RMPs) for marketed and developmental products and Risk Minimization Measures (RMMs) are compliant 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 compound.
Who You Are:
You have an MD or DO along with 2 years of Clinical Patient Care experience, 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products and 3 years of experience with medical case reviews, aggregate reporting, safety surveillance, signal management and/or risk management. You are or also have:
The 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
Ability to present drug safety topics for regulatory authorities at conventions, meetings, etc. Product defense before a national or international regulatory authority a plus
Drug safety database knowledge preferred
Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
Where You'll Work
This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements:
This position involves occasional US and domestic travel - up to 20%.
#LI-TB1
#LI-Remote
Pay Range:
$247,000.00-337,000.00 Annual
Life at Insmed
At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
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
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday.
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjg5MzE3LjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t
Place of Work
On-site
Requisition ID
R3539-3486
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