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Pharmacovigilance Team Manager


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
13-11-2016
Job Code:
58271615
Categories:
  • Biotechnology & Science
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Job Details

Manage, direct and control a Therapeutic Area Processing Team, responsible for the evaluation and consistent handling of Adverse Events and aggregated reports, ensuring compliance with reporting timelines and quality standards.Manage and lead processing team, liaising with CPO and third parties and ensure that all tasks are performed according to business rules, guidelines and standard operating procedures. 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. 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. 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. 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. 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. Support the Medical Safety Physicians in monitoring the safety profile of a product. Represent DS&E at internal and external meetings. Work with external partner groups, e.g. co-licensing partners and Clinical Research Organizations to meet joint accountabilities. Ensure the development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse event reports. Review, author and update SOP and support in global initiatives for ensuring enhanced quality and compliance. Involve in retention strategy and ensure associate engagement. Timely and high quality completion of safety administrator deliverables, according to established objectives. People development and managing attrition.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 4-5

Requirements

Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control | Research Scientist
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