MacHendar Goud

WORK HISTORY

EDUCATION

ABOUT MACHENDAR GOUD

Pharmacovigilance Professional | 5+ Years of ExperienceCareer Progression: Advanced from Junior Data Analyst to Associate Safety Scientist, with end-to-end expertise in Individual Case Safety Report (ICSR) management. ICSR Expertise: Skilled in intake/triage, clinical trial & PMS/spontaneous report entry, MedDRA/WHO-DD coding, narrative writing, validation checks, PV operations, and mailbox handling and leading MICC team. Regulatory Knowledge: Strong awareness of global PV regulations; maintains Safety Data Exchange Agreements (SDEA) and ensures compliance. Risk Management: Contributed to Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Pharmacovigilance System Master File (PSMF) reviews. Quality & Compliance: Experienced in QC review, reconciliation, RCA/CAPA, and strict adherence to SOPs and regulatory standards. Trial Master File (TMF) Management: Experience with eTMF platforms (Veeva Vault) to ensure \"high-quality\" and audit-ready documentationEDC (Electronic Data Capture): Understanding how data flows from the site to the sponsor (e.g, Medidata Rave, Veeva).Clinical Systems: Proficient in CTMS (Medidata/Oracle) for end-to-end milestone tracking, site monitoring oversight, and study-level reporting.Safety Reporting: Managed submissions to Health Authorities, prepared KPIs/compliance trackers, and supported DSUR/RMP activities. Literature Surveillance: Conducted global/local literature searches (PubMed, Embase), case qualification, and signal detection documentation. Technical Proficiency: Hands-on with ARGUS Affiliate, ArisG, Clinevo, EDC systems, and Power BI for metrics and database performance and DBS and QMS management. Therapeutic Diversity: Managed post-marketed and clinical trial cases across oncology, CNS, and device-combination products. Data Integrity: Oversaw reconciliation activities, QC steps, KPI/metric submissions, and vendor management.