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 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.

What You'll Do:

In this role, you'll have the opportunity to support the Medical Safety Lead in the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches. You'll also:

• 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.

Who You Are:

You must have a 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. Additionally, you have:

• 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 have (but not required):

• 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.

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 may be expected.

Travel Requirements

This role requires occasional domestic travel (up to 10%).

#LI-MM1
#LI-Remote

Pay Range:
$133,000.00-173,000.00 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.

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 TotalRewards@insmed.com 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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or
• An alternative selection process by emailing Privacy@insmed.com.
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.