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: Pharmacovigilance Team Manager
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 individual’s skills and potentials.
5. Set up the training plans for new hires according to the individual’s experience and job role and ensure that training is provided to team as appropriate. Support the training of other de-partments 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.
8. Support the Medical Safety Physicians in monitoring the safety profile of a product.
9. Represent DS&E at internal and external meetings.
10. Work with external partner groups, e.g. colicensing partners and Clinical Research Organizations to meet joint accountabilities.
11. Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports.
Key Performance Indicators (Indicate how performance for this role will be measured)
1. Number, timeliness and quality of deliverables according to established directives.
2. Recruitment, retention and development of talent in the team.
3. Accurate allocation and efficient usage of available resources within the team.
Job Dimensions (Indicate key facts and figures)
Number of associates: Direct reports 10-12
Financial responsibility: (Budget, Cost, Sales, etc.) None
Impact on the organization:
• Ensure training and promote motivation of team mem-bers.
• Ensure that all Adverse Events are processed by the team according to internal timeframes and Health Authorities requirements.
• Monitor the quality of team deliverables taking corrective actions as appropriate.
• Alert the medical safety expert to potential safety issues.
• Interact with other line-units to ensure consistent han-dling of adverse event reports.
Education (minimum/desirable): Minimum : 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
Preferred : MD or MS in Clinical Pharmacy, PhD in Life sciences or related fields
Languages: Good knowledge/fluency in English. Knowledge of other languages desirable.
• At least 4 - 5 years experience in drug development, including at least 2 years experience in safety or closely related areas of responsibility. At least 2 years experience in people management.
• Management experience or demonstrated leadership skills
Experience: 4-5 years
Education: B.Pharm, M.Pharm, B,Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical, R&D
Job Type: Full Time
Employment Type: Permanent
Job ID: 116023BR
End Date: 8th Apr, 2013
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