Senior drug safety associate
APCER Life Sciences
Total years of experience :9 years, 8 months
Quality Review of the spontaneous, literature, clinical trial, CIOMS and E2B reports.
Maintenance of Client quality tracker
Conducting trainings for the new client updates
Also did data entry of the various case scenarios
Preparing Minutes of meeting for the underwent meetings sessions
Assisting day to day queries as a subject matter expert
Assessment of the data corrections received and maintenance of a tracker
Providing proper feedbacks to the data entry associates to minimize the clients errors
Book-in and triage of the cases
Literature articles review for adverse events
Providing feedback sessions for the associates and giving appropriate trainings
As case processor:
To check for duplicate book-in.
Working as Case processor, doing full case data entry with MedDra coding, WHO DD and CDD DD drug coding on Argus
Case letter attachment.
To fully review the case entry and routing to Verifiers level.
Have processed different types of cases such as Spontaneous, Literature, CIOMS, Study cases, Clinical Trials, Legal cases, LP and NALP cases, Follow up cases. Having full command over Argus.
As Quality Analyst:
Checking the case going through each and every tab.
Checking coding of the drug, Last action and de-challenge/re-challenge assessment.
Checking Events coding and event outcome.
Generating peer review action item.
Routing the case to primary review.
traiining in production of medications