Patient Safety, Medical Director

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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$0 - $0

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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

About Vertex

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 and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visitwww.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.