Clinical Operations

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $63.38 - $74.57 per hour
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job description

Clinical Operations

Job Title: Clinical Project Lead V

Job Summary

  • The primary role of a Pharmacoepidemiologist (contractor) is to provide pharmacoepidemiology support to marketed and investigational products. More specifically, a Pharmacoepidemiologist (contractor) designs and leads implementation of pharmacoepidemiological studies, and provides pharmacoepidemiological support.
Job Responsibilities

  • Pharmacoepidemiology support to safety analysis activities
  • Conduct epidemiological literature review and/or analysis for signal evaluation and interpretation
  • Prepare the pharmacoepidemiologic section of the Risk Management Plan(s) pertaining to drug/vaccine safety and formulate pharmacoepidemiology studies/action plan as appropriate
  • Prepare responses to questions to health authorities regarding pharmacoepidemiology (epidemiological literature or epidemiological studies)
  • Pharmacoepidemiological studies and observational post-authorization safety studies (PASS)
  • Lead the development of pharmacoepidemiological studies and observational PASS including their design, conduct and interpretation in close collaboration with functions as needed (e.g. GSO, regulatory, statistician, clinical operations, affiliates)
  • Liaise with the other pharmaceutical companies and industry associations regarding collaborative studies as needed (e.g. Joint PASS)

    Liaise with external pharmacoepidemiology experts as needed
  • Management of pharmacoepidemiological data
  • Identify and determine efficient data collection approaches and data sources relevant for the questions being investigated
Education & Qualifications

  • PhD degree or Sc degree from an accredited graduate department of epidemiology or MD degree/pharmD degree/DVM degree with graduate training in Epidemiology or other public health. Candidates with MS or MPH degress with strong epidemiology training will be considered, too.
  • Relevant experience in epidemiological research.
  • In depth knowledge of pharmacoepidemiology methods and data sources.
  • Capability to clearly communicate complex epidemiologic issues to both the scientific community and the general public.
  • Written and verbal communication proficiency in English, including the presentation of data.
  • Demonstrated ability to formulate investigational plan and capability to work in crisis situations.
  • Teamwork, excellent interpersonal skills and proven time management skills.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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