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location: Northbrook, Illinois
job type: Contract
salary: $45.95 - 54.05 per hour
work hours: 9 to 5
- Provides specific pharmacoepidemiology expertise using appropriate methodologies and tools in researching the natural history of diseases and therapies in order to understand the standards of practice associated with the development of new chemical/molecular entities and/or use of the client's marketed products.
- Provide scientific leadership to internal and external cross-functional stakeholders (Clinical, Regulatory, Biostatistics, etc.) to design, develop and execute PE studies.
- Provide oversight for the development and execution of PE project timelines and deliverables.
- Collect, analyze and communicate PE data (such as incidence;/prevalence estimates, natural history of disease data) to Pharmacovigilance and Clinical Teams to support analyses and interpretation of safety data gathered from internal and external sources
- Provide scientific leadership to PSP in identification and implementation of new technologies and processes for enhancing safety surveillance and risk management.
- Collaborate with Risk Management to develop and manage product specific pre- and post-approval PE components of risk management strategies
- MPH or PhD in Epidemiology, Health Services Research, or related field.
- Epidemiology or Pharmacoepidemiology working experience (5+ years)
- Pharmaceutical industry experience (3+ years)
- Demonstrated expertise in utilizing pharmacoepidemiology principles, methodologies, and databases for pharmacovigilance projects
- In-depth knowledge of Clinical Development and Pharmacovigilance business processes
- Solid understanding of US and ex-US safety regulations
- Demonstrated experience in analytical study design and methodologies
- Strong leadership skills
- Team player
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
- Ability to create clarity on projects and teams in ambiguous situations.
skills: Pharmacovigilance, Pharmacoepidemiology, RMP (Risk Management Plan)
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.