Pharmacoepidemiologist
direct staffingSwiftwater (PA)
About the role
Pharmacoepidemiologist The Pharmacoepidemiologist is part of a dynamic Global Pharmacoepidemiology and Risk Management team within Global Pharmaco Vigilance Department (GPV) at Sanofi Pasteur. The main activities managed by the Pharmacoepidemiologist are: To design scientifically valid observational Post-Authorization Safety Studies (PASS) to fulfill Sanofi Pasteur's post-marketing commitments using Good Pharmacoepidemiology Practices (GPP) and European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) methodological guidelines Works closely with the Product Safety Officers (PSO) in the respective Safety Evaluation Group to support safety signal evaluation in internal and external databases (WHO Vigibase, US VAERS)Provides input into benefit-risk assessment for vaccines (both qualitative and quantitative) as required by the EMA's New Pharmacovigilance Legislation To bring epidemiological perspective, expertise and evidence-based recommendations in the identification and design of risk management plans (RMP), periodic risk-benefit evaluation reports (PBRER), and Safety Analysis Reports (SAR). He/she designs additional pharmacovigilance activities and risk minimization measures in RMP.Assists in the evaluation of external data sources for their utility in addressing vaccine safety related issues Provides background incidence rates of diseases, symptoms, and syndromes that are potential or identified safety risks. These rates may not be available and may require analysis of large observational / administrative databases. Provides critical review of relevant published literature Builds and maintains effective partnership with Global Medical Affairs, US Medical Affairs, Clinical Development and Regulatory Affairs departments Assists in the development of SOPs and Working Instructions Participates in ad-hoc requests or other activities as needed. These may include, but are not limited to teleconferences with the Health Authorities to discuss a pertinent safety issue, helping to maintain administrative database updates, and serving on internal or external workgroups.
Qualifications:
A Doctorate of Philosophy (Ph. D) degree is required, Epidemiology concentration preferred along with a minimum of two (2) years pharmacoepidemiology or pharmacovigilance experience in industry. Additional Skills/Preferences Effective communication of epidemiological strategy and findings, both written and verbal, is required. Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside Epidemiology, and to influence decisions. Knowledge of infectious diseases and vaccines is a plus. Good knowledge of biostatistical principles and applications. A sophisticated understanding of and the ability to interpret quantitative methods is required. Working knowledge of statistical analysis softwares (SAS, STATA). Experience in strategic planning and project management. Strong communications and organizational skills. Experience and proficiency working in cross-cultural/global teams.
Primary Location: United States-Pennsylvania-Swiftwater
Other Locations:
France-Rhone-Alpes-Lyon, Canada-Ontario-Toronto All your information will be kept confidential according to EEO guidelines. Direct Staffing Inc
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