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Post : Safety Processing Expert
Job Description:
1. Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database.
2. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.
3. Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy.
4. Use medical dictionaries and business guidances to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.
5. Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed.
6. Alert manager to potential safety signals based on incoming case reports.
7. Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased.
8. Assist with related administrative and procedural activities as required or requested.
9. Assists in the training of other Safety Processing Experts as necessary.
10. Support DS&E Projects or database validation activities as required.
Major Accountabilities (HR Core IT9102 ST9002)
Manage daily operation and complete the task as per require TAT.
Candidate Profile :
Master Degree in life Sciences with minimum 1-3 years experience in Case processing
Additional Information:
Job ID: 194567BR
Location: India
Division: Pharma
Business Unit: Global Develop NPH
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
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