Tirupathi Padmaja

Pharmacovigilance professional with 3+ years driving clinical, post-marketing, SUSAR, and literature safety operations. Expert in Argus Safety, Veeva Safety, ArisG, E2B reporting, MedDRA coding, and narrative writing, delivering accurate, GxP-compliant regulatory submissions while mentoring teams and optimizing workflows.

Associate Safety Specialist at Thermo Fisher Scientific (2024-05 – Present)

• Oversee the complete lifecycle of safety events including intake, assessment, medical review coordination, and regulatory documentation.
• Handle 10+ complex safety cases daily across SUSAR, clinical, post-marketing, and literature sources.
• Prepare, validate, and review E2B R2/R3 reports ensuring compliance with GxP and regulatory timelines.
• Communicate with physicians and investigators to obtain missing details, clarify case information, and ensure completeness.
• Serve as primary contact for clients, resolving discrepancies and providing regulatory guidance.
• Mentor team members on workflow optimization, regulatory updates, and best practices for safety evaluation.
• Implement process improvements and provide training on GxP adherence and regulatory standards.

Safety Associate at Tata Consultancy Services (2022-03 – 2023-08)

• Managed end-to-end safety events in ArisG database including documentation, coding, narratives, and follow-ups.
• Maintained consistent throughput of 8–10 complex events per day while achieving high data accuracy.
• Conducted data verification, reconciliations, and resolved discrepancies to maintain reliable safety information.
• Coordinated with affiliates and clients to obtain missing details and ensure case completeness.
• Trained new associates on workflow optimization, database usage, and regulatory expectations.
• Ensured adherence to GxP and internal SOPs in daily operations.

Master of Pharmacy in M.Pharm – St. Ann's College of Pharmacy, JNTUK (2024)

Bachelor of Pharmacy in B.Pharm – St. Ann's College of Pharmacy (2021)