Manager - Pharmacovigilance

Our client : One of the leading Pharma Company

Education : MBBS/ MD

Relevant Exp. required in PV is 4-7yrs

The Job Responsibilities for the position of Manager Pharmacovigilance, Ahmedabad is as under:

- Manage daily workload for individual case processing, literature searches, PSUR/PADER generation and any other tasks relevant to the Pharmacovigilance Department

- Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements

- Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities

- Be the safety lead for projects; to include set-up, project management, client liaison

- Be responsible for SAE reconciliation for a study

- Ensure that company is in compliance with the Company Standard Operating Procedures and with safety reporting requirements of regulatory authorities

- Ensure that company meets client expectations and requirements for safety reporting

- Provide regulatory consultation regarding safety reporting for investigational drugs

- Review serious adverse experience information received from investigative sites and assure compliance with regulatory reporting requirements

- Prepare/review safety section of regulatory reports, e.g. Annual Reports and Periodic Safety Update Reports

- Prepare SAE reporting plans

- Represent Pharmacovigilance group at project team, client and investigator meetings

- Prepare documents describing the process for monitoring and reporting serious adverse experiences (e.g., SOPs, user manuals)

- Liaise effectively and maintain excellent relationship with the clients and internal/external contacts

- Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities and communicate the same to management and to relevant members of the department in order to initiate any change in processes

- Build and maintain good relationships across functional units and company affiliates

- Train and mentor new employees in Pharmacovigilance

- Assist Business Development for client development presentations that involve safety reporting as a potential service; provide adequate input into client proposals

- Carry out necessary administrative duties required for the job

- Communicate, as required, with the UK/US office(s) and customers/clients in order to achieve required outcomes and meet timelines

- Other duties relevant to this position, as assigned by the management