Pharmacoepidemiologist

Pharmacoepidemiologist

The Pharmacoepidemiologist is part of a dynamic Global Pharmacoepidemiology and Risk Management team within Global PharmacoVigilance 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

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