Indhu Krishna

To establish a sustainable career by applying my knowledge and skills with a positive attitude, hard work, and confidence—contributing effectively to the goals of the organization.

Associate - Quality Assurance at Indegene (2021-11 – Present)

• Perform triage and intake of ICSRs received daily in the Argus database, ensuring timely processing in accordance with established timelines.
• Ensure accurate data entry of serious and non-serious ICSRs (Spontaneous, Solicited, and Literature) in Argus as per client SOPs and Work Instructions (WIs), maintaining a high level of data quality.
• Conduct follow-up activities for all serious and non-serious cases as per Good Pharmacovigilance Practices (EU-GVP) guidelines.
• Track and perform daily and monthly reconciliation of ICSRs in alignment with client requirements to ensure case accountability and reporting compliance.
• Schedule and conduct literature searches using PubMed and MLM to identify valid ICSRs.
• Perform quality checks of literature reports for accuracy and regulatory relevance.
• Monitor Health Authority websites regularly for safety updates and issues relevant to case reporting.
• Download and review ICSRs from EudraVigilance (EV) for valid cases.
• Perform quality checks for serious and non-serious ICSRs to ensure consistency, completeness, and compliance with regulatory and partner expectations.
• Conduct quality reviews of ICSRs by verifying case data against source documents and updating relevant information in the safety database.
• Responsible for generating safety reports and ensuring timely submission to Health Authorities and business partners.
• Responsible for writing descriptions and chronologies during weekly late case reviews and in deviation reports for cases submitted late to Regulatory Authorities.
• Analyzing root causes based on chronologies to support continuous improvement.
• Preparing CAPA (Corrective and Preventive Action) documents and comprehensive deviation reports.
• Liaising with clients regarding case processing activities, when required.
• Participating in project team meetings and providing feedback to the operations manager on process challenges, issues, and successes.
• Leading or supporting departmental initiatives to drive process improvements and efficiency.
• Performing additional duties as assigned in support of team goals.
• Ensuring 100% compliance with all organizational people practices, policies, and process.

Drug Safety Associate-II at Navitas Life Sciences (2020-01 – 2021-10)

• Perform triage and intake of ICSRs received daily in the Argus database, ensuring timely processing in accordance with established timelines.
• Ensure accurate data entry of serious and non-serious ICSRs (Spontaneous, Solicited, and Literature) in Argus as per client SOPs and Work Instructions (WIs), maintaining a high level of data quality.
• Conduct follow-up activities for all serious and non-serious cases as per Good Pharmacovigilance Practices (EU-GVP) guidelines.
• Track and perform daily and monthly reconciliation of ICSRs in alignment with client requirements to ensure case accountability and reporting compliance.
• Schedule and conduct literature searches using PubMed and MLM to identify valid ICSRs.
• Perform quality checks of literature reports for accuracy and regulatory relevance.
• Monitor Health Authority websites regularly for safety updates and issues relevant to case reporting.
• Download and review ICSRs from EudraVigilance (EV) for valid cases.
• Perform quality checks for serious and non-serious ICSRs to ensure consistency, completeness, and compliance with regulatory and partner expectations.
• Conduct quality reviews of ICSRs by verifying case data against source documents and updating relevant information in the safety database.
• Responsible for generating safety reports and ensuring timely submission to Health Authorities and business partners.
• Responsible for writing descriptions and chronologies during weekly late case reviews and in deviation reports for cases submitted late to Regulatory Authorities.
• Analyzing root causes based on chronologies to support continuous improvement.
• Preparing CAPA (Corrective and Preventive Action) documents and comprehensive deviation reports.
• Liaising with clients regarding case processing activities, when required.
• Participating in project team meetings and providing feedback to the operations manager on process challenges, issues, and successes.

Master of Pharmacy in Pharmacology – Sri Padmavathi School of Pharmacy (2019)

Bachelor of Pharmacy – Sri Padmavathi School of Pharmacy (2017)