Prathyusha Kaitha

About Prathyusha Kaitha

Experienced Medical Writer and PMS/PSUR & Risk Management Specialist with 8.5+ years of…

Experience

1. Lead Medical Writer

   4c Pharma Solutions

   May 2024 — Present · Telangana, IN

   Preparing and submitting PQRRs, CPMSRs, PRERs, and PSURs for medical devices in line with regulatory requirements and deadlines.2. Analysing safety data from clinical trials, post-market surveillance, complaints, and adverse event reports.3. Collaborating with cross-functional teams (Regulatory, Clinical, Quality, Medical Affairs) to gather safety data, including tracking MAUDE database inputs.4. Ensuring accuracy and completeness of PSURs through detailed data review and verification.5. Retrieving and interpreting data from literature and PMS databases, maintaining regulatory and internal compliance.6. Conducting hazard code trend analysis and signal trending for medical devices.7. Identifying serious incidents requiring reporting under IMDRF Adverse Event Terminology (AET).8. Maintaining current knowledge of global regulatory guidelines, including MDCG and device-specific PSUR requirements.9. Supporting audits and regulatory inspections with relevant documentation and safety reporting insights.10. Contributing to development and optimization of PSUR-related processes and SOPs.11. Participating in safety review meetings and recommend risk mitigation strategies.12. Communicating with regulatory authorities regarding PSUR submissions and follow-up queries.13. Staying informed on industry trends, pharmacovigilance practices, and evolving safety reporting standards.14. Documenting and describing CAPA actions within safety reports.15. Ensuring team deliverables meet quality expectations and KPIs per organizational standards. Possess sound knowledge of Issue Impact Assessment (IIA) and Health Hazard Evaluation (HHE).16. Demonstrating strong understanding of risk management principles and mitigation planning.

Skills

• Microsoft Excel
• Microsoft Office
• Leadership