Safety Systems Analyst

• The Safety Systems Analyst interfaces with both the Pharmacovigilance group within Medical Affairs Department and Global IT and responsible for identifying and defining adequate systems and databases to support consistent and accurate Pharmacovigilance data collection, data analysis, report generation, and submission tracking.
• This role facilitates user requirements gathering, implements user requirements and acts as a technical expert for designing customized/complex database solutions, queries and reports for internal and external customers, including regulatory authorities like FDA and EMA.
• This position requires a strong knowledge of Pharmacovigilance terminology and Database (e.g. Oracle AERS, ARISg, ARGUS) and excellent technical, analytical and problem solving skills pertaining to safety database systems.
• Individual should have excellent communication skills and interpersonal skills and should have the ability to learn quickly and train others within the team.
• Broad knowledge of relevant ICH guidelines, as well as FDA and EU Regulations is a Plus.

Bachelor's degree in scientific discipline, life- or computer science or equivalent

At least 3-5 years of previous experience in Data Management or related area

To know more about this position, please contact

Jeff Demaala

973-606-3249