Job Opening for Clinical Safety Team Leader @ India Novartis Healthcare Private Limited, Hyderabad

Posted on December 17, 2008. Filed under: Pharmaceutical | Tags: , , , |

Novartis

Novartis offers a wide range of healthcare products through our Pharmaceuticals, Vaccines and Diagnostics, Sandoz and Consumer Health Divisions.

Novartis Vaccines & Diagnostics is a new division of Novartis consisting of two business focusing on the development of preventive treatments and tools. Novartis Vaccines is the world’s fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the United States. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world’s blood supply.

This Job is posted in http://www.novartis.com  for more details visit http://www.novartis.com/careers/job-search/brassring/index.shtml

Job ID 31786BR
Posting Title Clinical Safety Team Leader
Division Pharmaceuticals
Business Unit General Medicines
Country India
Work Location India – Hyderabad
Company/Legal Entity India Novartis Healthcare Private Limited
Posting Functional Area Development
Job Type Full Time
Employment Type Permanent
Job Description 1. Manage and lead his/her team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures; Monitor workload and allocate resources appropriately.
2. Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
3. Maintain high level of compliance for processing of incoming adverse events reports by the team according to internal timeframes and Health Authorities requirements.
4. Communicate achievements, issues and actions regularly with Global Management
5. Set up yearly objectives and review performances of team ensuring best use of available re-sources. Discuss and set up development plans with/for all team members to further develop individual’s skills and potentials.
6. Facilitate training for new hires according to the individuals’ experience and needs.
7. Review entered case reports and monitor the quality of work produced by the team and implement quality improvement initiatives as appropriate.
8. Alert global management to potential safety signals based on incoming case reports
9. QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines.
10. Promote working relationships between Integrated Medical Safety and other groups such as; other members of Integrated Medical Safety, medical personnel, Clinical Data Management, Clinical Research, Marketing.
11. Play an active/leading role in cross-functional teams on safety matters/ Integrated Medical Safety special projects relating to investigational and marketed drugs.
12. Facilitate the training of other departments in clinical safety related procedures/regulatory obligations.
13. Support and work closely with manager to set group strategy and achieve group objectives.
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