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Identity6+ years of focused drug safety experience.
Exposure of Regulatory Authority audits.
Sound knowledge of MS office (Word, Excel, PowerPoint).
Managing and leading processing team and ensuring that all tasks are performed according to business rules, guidelines and standard operating procedures.
- Monitoring workload and allocating resources appropriately. Also, ensuring that incoming adverse events are processed by the team according to internal time frames to meet health authorities requirements.
- Monitoring the quality of work produced by the team and support quality improvement initiatives as appropriate. Providing feedback to team members on quality and trained team members as appropriate to improve quality.
- Involvement in development and implementation of proper corrective and preventive action (CAPA) and preparation of Noncompliance reports. Assume ownership of quality of reports and CAPAs.
- 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.
