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Clinical Project Lead V
Ref No.: 18-13050
Location: Bridgewater, New Jersey
Title - Clinical Project Lead V
Location - Bridgewater NJ.
​Duration - 04+ Months

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.
1. 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)
2. 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
3. Management of pharmacoepidemiological data
Identify and determine efficient data collection approaches and data sources relevant for the questions being investigated

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.