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
Job Description:
Major Activities (Describe main activities)
1. Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accu-rate 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 Investiga-tor 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 proc-essing 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 re-jection.
7. Co-author, together with te Medical Safety Physicians, all required regulatory periodic re-ports, collecting, organizing and presenting the available data.
8. Work with external partner groups, e.g. co-licensing partners and Clinical Research Organisa-tions 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, com-patibly with the timely processing/ production of individual case reports and regulatory peri-odic 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 in-vestigational 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
Candidate Profile:
Education (minimum/desirable):
Life sciences degree / Nursing background
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.
Additional Information:
Location: Hyderabad
Education: Life sciences degree / Nursing background
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 110733BR
End Date: 5th Feb, 2013
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