Senior Director, DSPV Medical Safety

Location: Bridgewater
Posted on: June 23, 2025

Job Description:

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 Senior Director is the DSPV medical expert for assigned products and maintains current knowledge of assigned product portfolio and safety profiles. This individual will provide the day-to-day direction to the Medical Safety Team to ensure business needs and priority tasks are efficiently completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety surveillance, risk management, and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customers. This position reports to the Executive Director (ED), DSPV and will provide coverage for the ED, DSPV during his absence. Responsibilities Leads strategic consultation, and guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, interpretation and appropriate management and communication of safety information for Insmed's portfolio of products in development. Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process for assigned products and development compounds. Delivers high quality and timely medical safety deliverables. Provides content and functional approval, as needed, for all safety documentation in collaboration with the Executive Safety Committee. Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information. Leads 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 for assigned products and development compounds. 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 ED of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products. Delivers key content of Risk Management documents (RMPs, REMS) of assigned products. Writes periodic reports for assigned products; provides medical interpretation, review, and approval for required reports. Shares DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal. Provides expert safety input to the clinical development program for assigned products and development compounds Leads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develops/provides input to product Benefit-Risk Assessments, Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk-Evaluation and Mitigation Strategies (REMS). Ensures, in collaboration with Regulatory Affairs labeling team, an accurate representation and communication of the safety profile of assigned products and development compounds. Prepares responses to inquiries from regulatory authorities on safety issues for assigned products. Leads the integrated safety input into all regulatory documents where required. Performs detailed assessment of safety profiles for Due Diligence project. Provides Drug Safety input for product recall issues or Health Hazard Evaluations and “Dear Health Care Provider” letters. Performs the medical review of all adverse event reports for seriousness, expectedness and causality. Maintains and evaluates Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and communicating metrics to appropriate teams and individuals. Identifies concerns and champions issue resolution. Leads all aspects of medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsource to vendors and contract research organizations (CROs). Evaluates, monitors, and oversees strategic drug safety company policies and regulatory requirements on safety data reporting, collection, surveillance activities, and documentation. Ensures that safety-related project landmarks are met within required timelines. Reviews scientific literature and 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. Ensures audit and inspection readiness of the function at all times. Job Requirements: M.D. or D.O. required; MPH (Master of Public Health) is a plus. 2 years of Clinical Patient Care experience strongly preferred. 8 years of pharmaceutical industry experience within Drug Safety/Pharmacovigilance working with both investigational and marketed products. 5 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. Experience presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. A background in providing product defense before a national or international regulatory authority is a plus. Must have excellent communication skills (verbal and written). Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines is strongly desired. Experience in drug development and clinical trial methodology with rare disease experience preferred. Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information. Experience leading roles in clinical or safety through the complete submission process. Experience in presenting clinical or safety data to major health authorities. Strong leadership skills including mentoring, motivating, directing, and fostering collaboration. Experience in leading cross-functional, multi-cultural teams. Ability to develop and maintain effective working relationships with subordinates, superiors, and peers. Strong negotiation and conflict management skills. Drug safety database knowledge preferred. Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat digital literacy. LI-MM1 LI-Remote Salary Range 283000-339000 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. 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. 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.

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