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.
Education & Qualifications
- 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
- 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.
- 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.