Experience in pharmaceutical industry; Safety or Regulatory department preferred 1-3 years hospital, patient care, or equivalent experience preferred
(optional)
This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a team member for individual case safety report processing and as case owner for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting.

Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
*Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter’s causality, and overall event resolution *Ensure that the correct suspect drug was selected within the Pharmacovigilance Safety System *Write narratives summarizing all relevant medical information for individual case safety reports *Code medical terms using standardized medical dictionaries (i.e. MedDRA). *Using medical expertise, ensure that all data has been entered and coded correctly in the Global Safety Database. *Request case investigation to gather all required medical information, including query generation, tracking, and follow up with reporters in conjunction with local affiliates *May perform quality checks as requested/necessary *May perform case cleanup as required for preparation of aggregate reports


Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
*Medical & clinical knowledge
*Excellent oral & written communication
*Operates effectively in a team environment
*Ability to work under strict deadlines and changing priorities with some supervision
*Able to multitask and prioritize changing workload on a daily basis
*Working knowledge of ICH guidelines and other worldwide safety regulations
*Ability to establish proficiency working with the Pharmacovigilance Safety System

Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Degree in nursing or pharmacy or equivalent