Anand Kurhadkar

About Anand Kurhadkar

Drug Safety Associate in Pharmacovigilance with experience in handling adverse event data, medical coding, Case triaging, Meeting Regulatory Timelines, and MedDRA coding.* Triage of incoming cases to prioritize for daily workflow management.* Updated and entered appropriate data into Clinical database and ensured data was captured according to departmental SOPs.* Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA and worked closely with the coding department.* Wrote narratives summarizing the events in chronological format according to departmental SOPs and did quality check of cases processed before reporting to the regulatory authority.* Administered the entry and revision of applicable information into the global safety database for initial or follow-up reports received via paper, fax or email.* Ensured regulatory compliance for individual expedited cases and case report submissions to Health Authorities or other receivers as appropriate.* Maintained an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations.* Participated in cross-functional training to ensure adherence to organizational policies and procedures.* Performed quality review and checking cases for discrepancies for any errors related to labeling and narrative writing.* Providing the support to team members for any case processing related queries and for any performance related issues.* Worked in Quality Check Tool team along with case processing. Reviewed cases for Offline E2B Checks and assigned corrections to associates across all sites.* Ensured incoming Adverse Events are processed accurately, provided internal feedback and training sessions to maintain quality and compliance to regulatory timelines.* Responsible for coordination activities for Quality Check tool team meetings including agenda, slide preparations, presentation etc.* Prioritized multiple tasks and deadlines to ensure all are completed on time.* Utilized technical skills to analyze and organize data.

Experience

1. Drug Safety Associate

   Indegene

   Oct 2023 — Present · Bengaluru, IN