New · posted Oct 31
Vertex Pharmaceuticals · Biotechnology
Patient Safety, Medical Director
- Boston, MA
- Hybrid
- Full-time
- Director
The role
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.
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 [email protected]
What you need
- 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.
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
What you'll do
- 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
Pay and benefits
Vertex Pharmaceuticals didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
$0 - $0
Medical, dental and vision benefits
Generous paid time off
Student loan repayment and educational assistance
Commuting subsidy
401(k)
Annual bonus and equity awards
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
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.
From the posting
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation.
Equal opportunity, accessibility and legal noticesVertex Pharmaceuticals's statements, word for word
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.
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts24 roles publishing pay
Director roles in the US69 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $217,500 | $229,000 | $281,000 |
| All US (middle half) | $213,500 | $260,000 | $281,000 |
Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs11
- Collaboration and leadership6
- Clinical trial conduct4
- Regulatory submissions3
- GMP and compliance2
- Quality systems and risk2
- Lab testing and methods1
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Vertex on Regulatory Jobs
- 46
- Open roles
- 46
- Distinct roles
- 2
- Locations
By discipline
- Clinical20 43%
- Quality15 33%
- Regulatory11 24%
By level
- Director39 85%
- Manager5 11%
- VP & Executive1 2%
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Patient Safety, Medical Director at Vertex
Open until filled.