Manager - Pharmacovigilance - BPO

Typical responsibilities include:

Responsible for ensuring that all Medical Review cases are processed in line with the SOPs and timelines as per the SLAs.

- Plan, organize, and manage daily work to meet service level timelines and deliverables.

- Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and UCB policies.

- Review all forms and documents pertaining to a case for errors, missing information, legibility.

- Provide guidance to the team members on the expedited cases.

- Provide medical input on difficult adverse event cases.

- Review and quality control of the serious and expedited cases as well as non serious cases.

- Responsible for submitting the final version of the Aggregate Safety Report to the client.

- Ensure US drug safety reporting regulations, ICH guidelines, and Client SOPs are applied by the team members to adverse event case reporting

- Evaluate team members- adverse event case reports for performance improvement.

- Adjust to changing regulatory environment.

- Identify, support, and implement continuous improvement activities.

- Responsible for escalating the issues or tasks outside the normal scope of work.

- Ensure effective and efficient resource utilization.

- Define or interpret day-to-day business objectives.

Other Responsibilities -

- Responsible for the championing of process enhancements to the team, and to senior management, functional and business leaders

- Responsible for compliance and quality.

- Identifies business development opportunities and communicates them to the Client Account Lead and senior management.

- Manages Service Improvement Programmes within the Delivery operation.

- Responsible for functional Operations staff and for maintaining headcount to the agreed plan.

- Recognised as having expert knowledge and vision in Client Delivery Operation.

- Ensures team attrition is at acceptable targets