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:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.

#LI-Hybrid

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