Analyst - GDPS

Responsibilities:

Adverse Event Case Processing -

· Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database

· Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate.

· Develop an understanding of pharmacovigilance regulations.

· Comply with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes as appropriate.

· Typical case processing activities include (but not limited to):

o Validation of data entry against source document(s) and call notes as appropriate.

o Assessment of adverse event reports for seriousness, reportability's and causality including reason for assessment.

o Perform self-review of all data for completeness, correctness and quality.

o Ensuring that the case is considered complete, acc...