Vertex Pharmaceuticals

Vertex Pharmaceuticals

Patient Safety, Medical Director

Boston, MA · Director

Sponsorship not specifiedDetected 6 hours ago
StatisticsRecruitingClinical TrialsPharmacovigilanceProblem Solving

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odds of building a lasting career here

38Risky
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 17 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 83%

Of 12 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 515 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

29 transfer filings in the last year, covering 29 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • The Patient Safety Medical Director will provide medical safety expertise for assigned products, pre- and post-approval.
  • 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

Responsibilities

  • Leads the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
  • Leads ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
  • Contributes to Partner/Affiliate agreements and interactions, as needed
  • Provides effective and relevant review of complex documents

Requirements

  • Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information

Skills

  • Broad and extensive knowledge of medicine, pharmacovigilance and relevant regulations
  • 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

Compensation

  • 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.

Benefits

  • Typically requires 5 years of experience with relevant experience in Safety/Pharmacovigilance, or the equivalent combination of education and experience
  • Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
  • Leads the development of safety-related responses to Safety queries from health authorities
  • 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
  • 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.
  • Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective

Company info

  • work remotely up to two days per week; or select
  • work five days per week on-site with ad hoc flexibility.
  • 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
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This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.