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Medical Director, Safety & Benefit-Risk Management

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: April 11, 2021

Job Description:

Medical Director, Safety & Benefit-Risk Management Job Description Reporting to a Disease-area Safety Head, the Medical Director of Safety and Benefit-Risk Management will provide medical safety expertise for assigned products, pre- and post-approval.

Key Responsibilities

  • Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
  • Optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle
  • Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head
  • Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
  • Lead the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
  • Lead the development of safety-related responses to Safety queries from health authorities
  • Identify, prioritize and analyze clinical safety signals, in accordance with GPS procedures
  • Perform ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
  • Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
  • Effectively contribute to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
  • Review and provide medical content, as needed, for key study-related documents, e. g.IB, ICF, IDMC Charter
  • Participate in departmental development activities including SOP and Work Instructions development
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
  • Provide a contributory role in Partner/Affiliate agreements and interactions, as needed
  • Other activities, as needed or as requested by GPS management
    Minimum Qualifications
    • MD degree or equivalent (e. g. , DO or MB) required
    • At least 5 years relevant Safety/Pharmacovigilance experience
    • Appropriate experience with Regulatory Agency and key stakeholder interactions
    • Experience with ICSR case review and Aggregate Safety analysis and reports
    • Experience with key Global PV/Regulatory approval activities, including NDA/MAA, RMP and REMS Preferred Qualifications
      • Broad knowledge of medicine, pharmacovigilance and relevant regulations
      • Extensive evidence of effective delivery of high quality safety relevant documents.
      • Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information
      • Effectively communicates in written and spoken English
      • Communicates complex issues in an understandable, effective and relevant manner.
      • Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
      • Strategic focus regarding activities, with proactive planning and prioritization skills.
      • Effective leader and team member
      • Takes ownership of appropriate issues and appropriately delegates
      • Technical expertise in pharmacovigilance and clinical safety
      • Excellent analytical and problem solving skills, with sound autonomy and applied judgment
      • Provide effective and relevant review of complex documents #LI-RS1 Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. Full time REQ-10890 About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) - a rare, life-threatening genetic disease - and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease. Founded in 1989 in--Cambridge, Mass., Vertex's global headquarters is now located in Boston's--Innovation District--and its international headquarters is in--London, UK. Additionally, the company has research and development sites and commercial offices in--North America,--Europe,--Australia--and--Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on--Science magazine's--Top Employers list and top five on the 2019 Best Employers for Diversity list by--Forbes. For company updates and to learn more about Vertex's history of innovation visit-- www.vrtx.com --or follow us on-- Facebook ,-- Twitter ,-- LinkedIn ,-- YouTube --and-- Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. Suggested Jobs Temporary Global Patient Safety Individual Case Safety Report Specialist Assoc Director Computerized Systems Audit and Inspection Management
        • Research System Associate Director - Cell and Genetic Therapies Posted Yesterday - Boston, MA, More... Associate Director, Audit Management, Cell & Gene Therapy

Keywords: Vertex Pharmaceuticals, Boston , Medical Director, Safety & Benefit-Risk Management, Executive , Boston, Massachusetts

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