Murali Mohan Raju Ambati

About Murali Mohan Raju Ambati

PROFILE SUMMARY: Had experience in Pharmacovigilance like case processing, intake, triage and quality check with MedDra Coding in both clinical trial and post marketing cases. • Skilled in mailbox management. • Had skilled knowledge in clinical pharmacology, pharmacy management, and research. • IT skills like ARGUS safety database, MedDRA dictionary, WHO dictionary, MS –office suite and EDC platforms like Inform 6.1 and Medidata Rave. PROFESSIONAL EXPERIENCE As Drug Safety Associate, IQVIA RDS (India) Private Limited, Kochi (From Sep-2019 to ongoing). INTAKE COORDINATION: Daily generation of SAE reports from electronic data capture (EDC). • Book-in of incoming cases or AE/ADR alerts from mailbox and SAE reports. • Triage to determine seriousness for prioritization of daily workflow. • Creation of source documents from EDC. CASE PROCESSING- experienced in CT and post marketing cases data entry and narrative. • Responsible for coding all medical history, concurrent conditions, concomitant medications, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). • Identifying suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events. • Writing narratives: Create complete, accurate and succinct narratives adhering to established processes. • Generating queries and communicating with sites and CRA\'s regarding queries and follow up for study related documents and investigational reports and query reconciliation in clinical trial cases. • Framing and sending query letter for follow up with the reporter in the post marketing.Quality review Other activities: • Pulling and publishing quality mails on daily basis. • Mailbox reconciliation. • Mailbox Archival activity. • Query letter follow up. • Internal Management Dashboard mails TOOLS/SKILLS Hands on experience with safety databases like Argus 8.1.1 EDC platforms like Inform 6.1 and Medidata Rave. Knowledge in pharmacovigilance, In-depth knowledge of pharmacy lingo and medical terminologies. Having good clinical knowledge on ICH-GCP Guidelines and doing research projects. Computer Proficiency: Familiar with Windows, MS word and Excel spreadsheet, SQL. An optimistic attitude in multitasking, prioritization and time management. Quick learner and good interpersonal skills. Typing speed 40 WPM. AMBATI MURALI MOHAN RAJU E-Mail: j••••••••@gmail.com Contact:+91••••••••22.

Experience

1. Senior Drug Safety Associate

   Accenture

   Aug 2022 — Present · Chennai, IN

   Hands-on expertise in end to end case processing in databases ARGUS and LSMV ArisG which includes- case intake/triage, data entry, safety narrative writing, quality review and follow up activities following the applicable global regulatory requirements.2). Responsible for coding all medical history, concurrent conditions, concomitant medications, events, drugs /procedures/ indications, and laboratory tests according to the appropriate dictionary For e.g, MedDRA, Company Product Dictionary and WHO-DD).3). Assessed labeling of serious adverse events orienting from spontaneous, clinical sources with reference IB, DSUR, CCDS, SmPC and USPI with help of CARA and internal forms.4). Adherence to timelines and process specified in SOPs and project-specific safety plan.5). Support in audit/inspection as Subject Matter Expert and develop CAPA to address safety findings.6). Worked in different therapeutics areas like oncology, neurology and hematology.7). Attended project team meetings and client calls related to the project.8). As mentor, trained and assisted new team members on safety data processing.

Education

• SRM University

  Doctor of Pharmacy - PharmD, Public Health

  2013 — 2019