Associate Medical Director, Global Patient Safety
The Patient Safety Associate Medical Director will provide medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development). This role will 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.
Key Duties and Responsibilities:
Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head
Monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS procedures
Performs ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
Represents the department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing guidance regarding safety matters and issues
Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
Participates in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
Contributes to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
Review and provides medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
Assists in departmental development activities including SOP and Work Instructions development
Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
Provides support in Partner /Affiliate agreements and interactions, as needed
Other activities as needed or as requested by GPS management
Knowledge and Skills:
Broad and extensive 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
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.
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
Appropriate experience with Regulatory Agency and key stakeholder interactions
Experience with ICSR case review and Aggregate Safety analysis and reports
Education and Experience:
MD, DO or equivalent ex-US medical degree
Typically requires 3 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experience
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.