Vertex Pharmaceuticals

Vertex Pharmaceuticals

Patient Safety Epidemiology Associate Director

Boston, MA · Director

Sponsorship not specifiedDetected 12 hours ago
Project ManagementRecruitingPharmacovigilanceResearchExperimental DesignCommunicationPublic SpeakingEpidemiology

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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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About the role

  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
  • Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1.
  • Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2.

Responsibilities

  • Expected to research the epidemiology of specific disease areas and events of interest, lead evaluation of data sources and data collection approaches, apply subject matter expertise in the design of observational studies, develop epidemiology sections for regulatory documents, and lead the post-marketing regulatory research strategy implementation
  • Leads all stages of the design and implementation of regulatory post-marketing studies: from feasibility assessments, development of study designs and protocols, and execution of studies, to communication and dissemination of results to internal and external (e.g., Regulatory Agencies, scientific communities) stakeholders
  • Leads the development of epidemiology sections for Risk Management Plans (EU RMP, REMS, etc.) and other regulatory filings (NDA, PSUR, etc.) for products throughout lifecycle
  • Leads systematic and targeted epidemiologic literature reviews to support safety evaluation and / or post-marketing research strategies
  • Supports signal detection analyses of safety reporting system databases (FAERS, Vigibase) or other sources (e.g. Sentinel)
  • Leads study execution teams for post-marketing regulatory studies
  • Collaborates cross-functionally to support company strategy for observational research, integrating innovative study methodologies

Skills

  • Specialized knowledge in pharmacoepidemiologic methods, pharmacovigilance regulations, and specific therapeutic areas
  • Strong knowledge in pharmacovigilance guidelines and regulations
  • Excellent independent decision-making skills
  • Strong project management skills
  • Education and Experience:
  • PhD in epidemiology is 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 in pharmaceutical/biotechnology industry, CRO, or academic setting or the equivalent combination of education and experience
  • Major contributor and driver to the company safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies

Company info

  • work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
  • 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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