Clinical Research Scientist Job Vacancies-Novartis HyderabadJune 11th, 2010 Posted by VFreshers
About Company :
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.
Job Position : Safety Processing Expert
Experience : 1 – 3 Years
Work Location : Hyderabad / Secunderabad
Job Responsibilities :
- Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for Novartis drugs.
- Responsible for the receipt, tracking and initialization of single case drug safety reports in to the safety database; accurate data entry and coding of adverse event reports and evaluation of non-expeditable reports within well defined timeframes, in compliance with DS&E business rules, standard operating procedures and regulatory requirements.
- Receive information on adverse events, perform initial checks, search database to prevent du-plicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database.
- Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.
- Evaluate and finish processing of non-expeditable AE reports, including review for complete-ness and accuracy.
- Use medical dictionaries and business guidances to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case.
- 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.
- Alert manager to potential safety signals based on incoming case reports.
- Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigi-lance Leaders to ensure that reports are accurately collected, evaluated and databased.
- Assist with related administrative and procedural activities as required or requested.
- Assists in the training of other Safety Processing Experts as necessary.
- Support DS&E Projects or database validation activities as required.
- 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
- MD or MS in Clinical Pharmacy, PhD in Life sciences or related fields
- Good knowledge/fluency in English. Knowledge of other languages desirable.
- Ability to write clearly and concisely
- Prior Medical Transcription or Medical Writing experi-ence preferred
- Previous safety or clinical trial experience desirable, but not essential
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