Freshers Jobs India

Clinical Research Scientist Job Vacancies-Novartis Hyderabad

June 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.

Required :

  1. 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
  2. MD or MS in Clinical Pharmacy, PhD in Life sciences or related fields
  3. Good knowledge/fluency in English. Knowledge of other languages desirable.
  4. Ability to write clearly and concisely
  5. Prior Medical Transcription or Medical Writing experi-ence preferred
  6. Previous safety or clinical trial experience desirable, but not essential

Website http://www.novartis.com/

Apply : If you have registered your CV with Naukri.com CLICK HERE to apply


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