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Risk Management Director and Medical Reviewer
Insmed Incorporated
2024-09-24 05:38:55
Bridgewater,
New Jersey,
United States
Job type: fulltime
Job industry: Executive Positions
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
Named Science's Top Employer in 2021, 2022, and 2023
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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three 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 role of Risk Management Director will oversee the Risk Management System (RMS) including the process for signal detection and safety issue assessment, and for leading any related risk assessment, management or epidemiologic activities at all stages of the product life cycle (clinical to post-marketing). This individual ensures risk management planning and implementation activities are consistent with US, EU and international guidelines and regulations. The individual will utilize industry best practices to ensure thorough monitoring of safety signals, and applicable risk mitigation strategies are in place as appropriate. As Medical Reviewer, this individual will ensure that the safety data are evaluated medically and put in context thus underpinning risk management initiatives. This individual will have responsibility for medical assessment and medical review activities 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 and may contribute to safety sections of safety and non-safety documents. Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following: Risk Management
- Leads the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for all products.
- Chairperson of DSPV internal safety signaling and review committee and an integral member of potentially other internal multi-disciplinary teams as assigned.
- Additional representative responsibilities will include, but not necessarily be limited to, the following: Leads the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for all products.
- Chairperson of DSPV internal safety signaling and review committee and an integral member of potentially other internal multi-disciplinary teams as assigned.
- Ensures 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.
- Collaborates with the Risk Management Pharmacovigilance Specialist in the finalization and implementation of RMPs and RMMs including strategically relevant content material and activities related to the safety profile of Insmed Products
- Support any applicable regulatory submissions including Marketing Authorization Applications (MAA), New Drug Applications (NDA) and Biologic License Applications (BLA).
- Oversight and Management of safety signals to ensure appropriate documentation, collaborate on the production of Safety Signal Assessment Reports in collaboration with Safety Physicians to assess and track safety signals.
- Directs and collaborates on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed.
- Directs and collaborates on the development of Risk Management Plans (RMPs/dRMPs), as required for marketed and investigational products.
- Assure successful completion of any future RMP commitments including post-authorization safety studies (PASS) and measuring the effectiveness of any risk minimization strategies.
- Manages process related to the REMS delivery team and general oversight of REMS programs where a REMS would be required.
- Ensure sound safety analysis and responses to regulatory query as applicable, including in response to PBRER assessment report, and analysis of safety data requests from Health Authorities in collaboration with safety physicians.
- Functions as a subject matter expert internal to DSP for epidemiology and provides in-house epidemiology expertise to other departments upon request and providing 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.
- Consults with safety systems programmers in the development of standard adverse event and tables generated for signal detection.
- Draft SOPs and work instructions related to risk management, epidemiology and signal detection.
- Oversight of the medical review of all adverse event reports and providing medical significance and assessment of seriousness, expectedness and causality of AE/SAE reports
- Approving AE/SAE case narratives prepared by vendors or Insmed and assist PV Scientists and designated safety vendors with medical opinion on obtaining follow-up information for individual cases.
- Compiling analysis of similar events (AOSE), individual case comments, RMP analyses, and ad-hoc safety analyses as required by health authorities or corporate policy.
- Provide medical input for maintaining RMP and post-marketing safety monitoring commitments
- Participate in review of scientific literature as needed, to identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required periodic reports.
- Provide periodic benefit-risk assessment reports for internal use
- Investigating and reviewing emerging safety data from various sources including individual clinical trial AE/SAE case reports, spontaneous Adverse Drug Reaction (ADR) reports, published literature, aggregate reports, toxicology reports, non-clinical studies, and other sources
- Contributes to the preparation and review of aggregate safety reports required by health authorities such as, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), US Periodic Adverse Drug Experience Report (PADER), etc.
- Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package and labeling.
- MD. or D.O (US or Internationally trained) preferred
- At least 3 years of Clinical Patient Care experience preferred
- At least 3 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products
- Experience in Risk Management and Applied Epidemiology, Signaling and Clinical Safety management preferred
- 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
- Strong skills in the management of safety information originating from both clinical development and post-marketing sources
- Expert knowledge of the regulations governing pharmacovigilance
- Working knowledge of industry standard pharmacovigilance databases (e.g. ARGUS or ARISg) and MedDRA and proficiency in performing data mining activities for analysis of safety data
- Strong Leadership skills and excellent communication skills with individuals at all levels (administrative to key thought leaders)
- Highly proficient in computer skills (Microsoft Word, Excel, PowerPoint, Outlook, Adobe Acrobat)
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
- Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven . click apply for full job details