Saishiva Vernekar

Senior Pharmacovigilance Officer @Indegene

Bengaluru, IN

Responsible for the QA review of ICSRs for completeness, accuracy, medical relevance and overall consistency of information captured in the ARGUS safety database against all the applicable supporting documents as per the client requirement. Review of the follow-up information to identify if it is medically significant or relevant and proceed with necessary actions. Review the narrative to ensure all the information has been captured in a systematic manner as per the client requirement. Review to ensure if additional queries are raised by the respective stakeholders for any missing data or clarification and document appropriately in the safety database. Perform quality assurance review as required and QC of applicable data in the client tools as appropriate.Managing the daily case assignments, tracking, process related and administrative work. Completed train the trainer program and handling the training of new hires end to end in the project. Communicate the QA observations to the applicable stakeholders and ensure the appropriate RCA or CAPA is obtained from the respective stakeholders for the applicable QA observations as per the client’s requirement. Presentation of the QA data to the responsible stakeholders in an appropriate forum as required. Rectifying narratives. Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project−specific guidelines.

Kle college of pharmacy, hubli

M.pharm

Government college of pharmacy,Bangalore

B.pharm

Govt arts and science college, karwar

Pre university

Balmandir Karwar

High school

St.joseph's school, karwar

Primary school