JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
Pharma
Company Size
Big > 5000
Requested Expertise
Epidemiology / Real-World Evidence / Health Economics & Outcomes Research
Profile Required
Requirements:
§ PhD in Epidemiology and/or pharmacoepidemiology or equivalent advantageous
§ At least 5-year experience in epidemiology/ pharmacoepidemiology as well as in drug safety
§ At least 3-year experience in CRO (pharmacoepidemiology) or pharmaceutical industry
§ Proven experience in executing pharmacoepidemiology studies using RWD, including CPRD
§ Experience in oncology epidemiology preferred
§ Excellent written and oral communication skills in English
§ Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
Project Description
Purpose of the role:
§ to design and execute Epidemiology activities and studies adressing safety research questions in the context of drug development, regulatory submissions, and marketed products,
§ to identify epidemiological / pharmaco-epidemiological methods, relevant data sources, best suited to address safety research questions
§ to transfer epidemiologic expertise and deliverables to the evaluation, refinement and contextualization of safety findings and potential signals, evaluation of safety signals (including literature reviews), as well as to the preparation and update of Epidemiology content in safety and regulatory documents (including but not limited to Risk Minimization Plan, FDA/EMA Orphan Drug Designation)
§ to conduct the feasibility, design, preparation of study concepts, protocols, and statistical analysis plans, know-how transfer to analysis execution for the Epi analytical team, and report of pharmacoepidemiologic studies of assigned DS products in line with the strategic epidemiology plan
§ evaluating the feasibility of establishing multiple indication cohorts for RWE generation using CPRD and other RWD sources
Therapeutic Area
Oncology
Language
English
Hard Skills
Soft Skills
Seniority Level
Experience > 10 years,Experience 5 – 10 years
Starting Date
2025-05-01
Project Duration
1 year
FTE / nb of days per week
5
Project Location
UK (full remote OK), United Kingdom
Remote Flexibility
Yes
Travel Expected
Yes
Approximative Budget
Any other information of interest
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