A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Post: Safety Processing Expert
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 complete-ness 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 Pharmacovigi-lance 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.
Education (minimum/desirable): Minimum: Medical Degree (MBBS) or Bachelors Degree in Pharmacy or Advanced Nursing Degree or Masters Degree in life sciences or related fields; or equivalent combination in educational credentials and experience.
Preferred: MD or MS in Clinical Pharmacy, PhD in Life sciences or related fields
Languages: Good knowledge/fluency in English. Knowledge of other languages desirable.
• Familiarity with medical terminology
• Ability to write clearly and concisely
• Self motivation and proactive stance to work
• Sense of urgency and commitment for timely comple-tion of activities
• Prior Medical Transcription or Medical Writing experi-ence preferred
• Previous safety or clinical trial experience desirable, but not essential
• Previous data entry experience desirable, but not essential.
Education: M.Pharm, MBBS, Ph.D, MS/MD
Functional Area: Healthcare, Medical, R&D
Industry Type: Pharma/ Biotech/Clinical Research
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