Job Description
General Summary :
The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval. The role will optimize 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 Global Patient Safety (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
- Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
- Leads the development of safety-related responses to Safety queries from health authorities
- Identifies, prioritizes and analyzes clinical safety signals, in accordance with GPS procedures
- Leads ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
- Represents 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
- 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 the preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
- Reviews and provides medical content as needed, for key study-related documents, e. g. IB, ICF, IDMC Charter
- Contributes to 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
- Contributes to Partner / Affiliate agreements and interactions, as needed
- Provides effective and relevant review of complex documents
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
- 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
Education and Experience :
- MD degree or equivalent (e. g. , DO or MB) required
- Typically requires 5 years of experience with relevant experience in Safety / Pharmacovigilance, or the equivalent combination of education and experience
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally.
In this Hybrid or On-Site-Eligible role, you can choose to work :
1. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
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