Manager, Pharmacovigilance & Epidemiology (PVE)
Manager, Pharmacovigilance & Epidemiology (PVE)
Exciting Contract Opportunity for an Epidemiologist/Observational Research Scientist with one of the Top Pharma clients.
Role Expectations:
- Perform feasibility analysis for studies
- Plan observational studies and draft protocol synopsis (or protocol concept sheet)
- Determine observational study design criteria - including source data, analytical methods and analysis plans
- Draft and review observational study protocols
- Draft and review observational study analysis specifications, including statistical analysis plans (SAPs)
- Draft and review observational study reports
- Conduct observational studies, both primary data collection and secondary data use studies
- Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications
- Conduct quality review of all deliverables to ensure data and results are accurate
- Work with scientific and operational stakeholders to identify and resolve issues
- Collaborate with study teams, vendors and other stakeholders to advance study and analysis deliverables
- Work with relevant stakeholders to meet study milestones and timelines
- Participate in program or study planning meetings
- Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
- Perform other related duties as required by the Department.
Experience/Qualifications:
- Graduate degree (MSc or/and PhD) in Epidemiology
- (7 - 10)+ years industry experience as an epidemiologist/observational research scientist
- Virology RWE/RWD experience required, HIV focus preferred.
Required skills
- Epidemiology
- Virology
- RWE/RWD
Reference: 52340032
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