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 them one of the most rewarding employers in their field.
Post: Clinical Safety Scientist
Major Activities (Describe main activities)
1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timeliness and quality.
2. Ensure accurate and consistent coding of medical history, drugs and adverse event terms.
3. Assess adverse event reports for seriousness, causality and expectedness as per the Investigator Brochure/Basic Prescribing Information/US package insert, consulting the Medical Safety Expert whenever needed.
4. Determine the necessity for follow up and prepare follow up request as needed.
5. Work in conjunction with Clinical Safety Associates, Clinical Safety Scientists from other processing sites and Medical Safety Physicians (Pharmacovigilance Leader and Brand Safety Leader) to ensure that reports are accurately evaluated and databased.
6. Triage literature cases for databasing or pass them on to the Team Leader for approval of rejection.
7. Co-author, together with the Medical Safety Physicians, all required regulatory periodic reports, collecting, organizing and presenting the available data.
8. Work with external partner groups, e.g. colicensing partners and Clinical Research Organisations to meet joint accountabilities
9. Represent DS&E at internal and external meetings
10. Assist the Medical Safety Physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.
11. Assist the Medical Safety Physicians in monitoring the safety profile of product
12. Be involved in development and testing of safety systems/IT applications and in the prepara-tion of relevant manuals.
13. Participate in cross-functional teams on safety matters/DS&E special projects relating to investigational and marketed drugs Impact on the organization:
• Ensure that Serious Adverse Event / Post Marketing Adverse Event are evaluated accurately and within the required timeframes to meet regulatory requirements
• Alert the Medical Safety Physicians to potential safety issues
Education (minimum/desirable): Life sciences degree / Nursing background
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Languages: Good knowledge/fluency in English. Knowledge of other languages desirable.
Experience/Professional requirement: Experience in drug safety / Development or closely related areas of responsibility
Experience of safety document writing
Good negotiation and oral communication skills
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Type: Full Time
Employment Type: Permanent
Job ID: 92492BR
End Date: 15th April, 2012
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