Shwetal Gaikwad

Detail-oriented pharmacovigilance professional with 4+ years' experience in drug safety operations and regulatory compliance. Skilled in signal detection management, ICSR processing, AE reporting, reconciliation, safety data exchange agreement, source data verification, and maintaining audit-ready systems to support compliance and patient safety.

Drug Safety Specialist - Personal Homecare Pharmacy - Leicester, United Kingdom

(2025-11)

• Lead recording, evaluation, reporting and tracking of adverse drug reactions (ADRs) and medical device reports, ensuring compliant end-to-end case processing in the global safety database
• Oversee intake, triage, initial case assessment (seriousness, expectedness, causality, reportability) and timely expedited reporting in accordance with GVP and global regulatory requirements
• Ensure accurate data entry, MedDRA and WHODrug coding, narrative preparation and quality review of ICSRs, maintaining traceability and data integrity
• Manage reconciliation between clinical, quality and pharmacovigilance databases and ensure inspection-ready documentation
• Drive continuous signal management including signal detection, validation, prioritisation, evaluation and safety trend analysis across data sources
• Conduct and supervise global and local literature review for signal identification and safety surveillance
• Lead preparation and review of periodic safety reports (PSURs, PBRERs) and support aggregate safety data analysis
• Perform and contribute to benefit-risk assessments based on signal evaluation, literature findings and safety data trends
• Maintain pharmacovigilance quality system documentation including SOPs, Risk Management Plans (RMPs), PSMF contributions and training records
• Provide technical and medical support for clinical trials including protocol review, study reports, medical monitoring and safety data handling
• Collaborate cross-functionally with Medical Affairs, Regulatory Affairs, Quality Assurance, Clinical teams and CROs to address safety issues and medical inquiries
• Lead pharmacovigilance inspections and audits, ensuring quality assurance, compliance monitoring and CAPA development
• Monitor KPIs, perform quality trend analysis and drive continuous process improvements in case processing and signal management
• Serve as pharmacovigilance liaison and subject matter expert for stakeholders and health authority safety requests
• Provide pharmacovigilance training and ensure proper archiving, documentation maintenance and regulatory compliance

Senior Drug Safety Associate - Cognizant Technology Solutions Pvt. Ltd.

(2021-02 - 2023-07)

• Managed SDEAs, deviations and CAPAs ensuring compliance with GVP guidelines
• Conducted Source Data Verification (SDV) and escalated discrepancies appropriately
• Trained associates on end-to-end case processing and pharmacovigilance requirements
• Performed safety data reconciliation between clinical and PV databases reducing duplication by 85%
• Performed case allocation, case intake, triage and processing of adverse event reports from clinical trials, literature and post-marketing sources
• Conducted initial assessment of seriousness, expectedness, causality and reportability following global PV procedures
• Performed data entry, MedDRA coding and quality review of ICSRs in Argus Safety database
• Identified missing information and conducted follow-up activities with reporters
• Supported expedited reporting to regulatory authorities within timelines
• Assisted in aggregate report preparation (PSURs, PADERs) and signal monitoring
• Served as pharmacovigilance liaison to cross-functional teams including Regulatory Affairs and Medical Affairs
• Maintained audit-ready pharmacovigilance documentation for inspections and audits

Drug Safety Associate - Cognizant Technology Solutions Pvt. Ltd.

(2020-02 - 2021-02)

• Processed 35+ ICSRs/day including adverse event intake, devices intake triage and follow-up activities
• Prepared case narratives ensuring accuracy, consistency and regulatory compliance
• Performed MedDRA and WHO-DD coding (suspect product and event coding) ensuring accurate safety database entry
• Prepared case narratives and supported expedited regulatory submissions
• Managed AE tracking and reconciliation activities

MSc - Pharmacology and Biotechnology - Sheffield Hallam University (2023-09 - 2024-09)

Bachelor of Pharmacy - Pharmacy - MAEER's MIT College of Pharmacy (2015-08 - 2019-07)