Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Science's Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma , Best Workplaces in New York , PEOPLE Companies That Care, Best Workplaces for Women , Best Workplaces for Millennials , and Best Medium Workplaces lists.
Overview
The Medical Director is the DSPV expert for assigned products and maintains current knowledge of the assigned product portfolio and safety profiles for products. This individual is 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. This role provides DSPV support for internal and external customers.
Responsibilities
- Reviews 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.
- Conducts safety signal detection activities, monitoring, evaluation, interpretation, and appropriate management and communication of safety information.
- Provides 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.
- Leads the development and management of a comprehensive risk management system for risk detection, risk assessment, and risk minimization for assigned products.
- Provides 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).
- Works with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
- Advises and collaborates on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed for assigned products.
- Ensures Risk Management Plans (RMPs) for marketed and developmental products and Risk Minimization Measures (RMMs) are aligned with US, EU, and international regulations and standards including ICH and EU GVP.
- Provides input into and support of the writing of periodic reports for assigned products; provides medical interpretation, review, and approval for required reports.
- Shares 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.
- Provides expert safety input to the clinical development program for assigned products and development compounds.
- Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
- Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of products and compounds.
- Responds to inquiries on safety issues, including responses to periodic assessment reports and analysis of safety data requests from regulatory authorities.
- Provides coordinated safety input into all regulatory documents where required and
- Performs detailed safety profile assessment for Due Diligence project.
- Provides Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters.
- Ensures that the safety data are evaluated medically and put in context thus underpinning risk management initiatives.
- Assists PV Scientists and designated safety vendors with medical opinion on acquiring follow-up information for individual cases.
- Serves as a subject matter expert internal to DSP for epidemiology and provides in-house epidemiology expertise to other departments upon request. Provides estimates of incidence and prevalence of health conditions, disease progression and disease-specific risk factors.
- Provides epidemiologic consultation on the identification and assessment of safety risks, safety data interpretation as well as observational study and registry design, as needed.
- Participates in review of scientific literature: identifies case reports that meet criteria for entry into the safety database; identifies relevant safety articles / references involving the active ingredients of marketed products and products in development; and builds literature summary sections to be included in PSURs and other required reports.
Position Requirements:- M.D. or D.O (US or Internationally trained) preferred; MPH (Master of Public Health) is a plus.
- At least 2 years of Clinical Patient Care experience preferred.
- 5+ years of proven experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products.
- 3+ years of demonstrated experience with medical case reviews, aggregate 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.
- Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.
- Conducting product defense before a national or international regulatory authority is a plus.
- Drug safety database knowledge preferred.
- Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat digital literacy.
- Must have excellent communication skills (verbal and written).
Salary Range
67
Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:
- Flexible approach to how we work
- Health benefits and time-off plans
- Competitive compensation package, including bonus
- Equity Awards (Long-Term Incentives)
- Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here .
Additional Information
Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law.
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 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.