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Job Description

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

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