Pharmacovigilance Team Manager
Novartis Healthcare Pvt. Ltd.
Job Description
- 1. Manage and lead processing team and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures.
2. Monitor workload and allocates resources appropriately. Ensure that incoming Adverse Events are processed by the team according to internal timeframes to meet Health Authorities requirements.
3. Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate. Provide feedback to team members on quality and train team members as appropriate to improve quality.
4. Set up yearly objectives and review performances of team ensuring best use of available resources. Discuss and set up development plans with/for all team members to further develop individuals skills and potentials.
5. Set up the training plans for new hires according to the individuals experience and job role and ensure that training is provided to team as appropriate. Support the training of other departments in clinical safety related procedures/regulatory obligations.
6. QC periodic regulatory safety reports before submission to management approval and ensure compliance with required timelines and co-author, together with the Medical Safety Physicians, periodic regulatory safety reports, as appropriate.
7. Interact with the Medical Safety Physicians on project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.Company Profile:
Novartis Healthcare Pvt. Ltd.
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
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