Job Description

Summary:

Minimum 3 years of experience in Pharmacovigilance. 2-3 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 subject matter expert 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 *Perform quality checks both in line and retrospectively as needed *May perform case cleanup as required for preparation of aggregate reports *May participate in compliance monitoring related activities including CAPA and Quality Control Metrics. *May perform reconciliation activities with organizations both within client and outside of the client. *Train and mentor new hires


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 and clinical knowledge *Excellent analytical & problem-solving skills *Excellent oral and written communication *Collaborative interpersonal skills to foster a team environment *Ability to work independently under strict deadlines and changing priorities *Able to multitask and prioritize changing workload on a daily basis *In-depth knowledge of worldwide and regional safety regulations *Ability to establish priorities *Proficiency in a Global Safety Database (e.g., ARISg, Argus) *Knowledge of multiple therapeutic areas and case source types


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, pharmacy or science degree or equivalent.