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Safety Processing Expert


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
13-11-2016
Job Code:
58271844
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

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 guidance 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 database.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.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 4-9

Requirements

Data Management/ Statistics | Documentation/ Medical Writing | Drug Regulation | Quality Assurance/ Control
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