Swetha Dandala

• Assessed, triaged and data entry of Individual Case Safety Reports (ICSRs) into safety database to support regulatory compliance.
• Responsible for case processing of ICSRs including Clinical trials, Spontaneous, Solicited, Literature, Post-box cases.
• Request follow-up and perform query management.
• Performed literature articles review.
• Managed coordination of client safety mailbox operations, ensuring prompt response and improved workflow efficiency.
• Leveraged Rave EDC, Veeva Vault, and Roam Reviewer to ensure thorough validation documentation and review compliance.
• Contributed to multiple projects to enhance expertise and achieve team goals.
• Worked on databases such as Argus and ARISg.
• Collaborated with medical reviewers, team leads, and clients to ensure compliance and data accuracy.
• Ensured timely completion of trainings and compliance deliverables.
• Performed quality review of ICSRs and provided feedback to team members.
• Collaborated with cross-functional teams to enhance pharmacovigilance processes and reporting systems.
• Experienced in working with Gen AI tools to improve productivity across projects.
• Participated in quality improvement projects aimed at reducing errors and enhancing the overall patient experience.

• Triaged Individual Case Safety Reports (ICSRs) for completeness, accuracy, legibility, and validity.
• Performed comprehensive data entry of case reports into safety database to support regulatory compliance.
• Evaluated case reports to determine seriousness, causality, and expectedness.
• Executed coding of events, medical history, and concomitant medications to ensure accurate documentation.
• Responsible for case processing of ICSRs including Spontaneous, Solicited, Literature, MLM, MHRA, Health authority cases from various regulatory authorities.
• Evaluated information requirements and conducted follow-ups to ensure resolution of queries.
• Contributed to multiple projects to enhance expertise and achieve team goals.
• Worked on databases such as Argus and ARISg.
• Collaborated with medical reviewers, team leads, and clients to ensure compliance and data accuracy.
• Ensured timely completion of trainings and compliance deliverables.
• Prioritized deliverables to accomplished work in critical times.