Ruthra Kumar S

Experience

1. Drug Safety Associate Trainee

   IQVIA India

   Aug 2024 — Present · Kochi, IN

   Performed initial check to prevent duplicate entries, triage of safety cases, creating case (book in) in database and process case files according to Standard Operating Procedure (SOP). •Data entry of safety cases in LSMV processing non-serious and serious cases, Literature, Clinical trials, both solicited report (post marketing studies, non- interventional studies, health authority, license partner, patient-oriented program) and unsolicited report (spontaneous report, report from other sources and digital engagement asset). •Ensure accurate product selection, consistent manual coding of all required adverse events, medical history, lab values and process quality investigational records and complete narrative for ICSRs by checking information from source documents. •Assessment of seriousness, causality and expectedness of adverse events (AE) using standard reference documents. •Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries. •Prioritization and submitting the cases within regulatory timelines. •Review the impacted cases daily and reroute the cases as need to ensure timely completion. •Receive quality feedback in case management and coding on daily basis. •Adhere to meet both internal and external quality standards. •Always adhere with the ICH-GCP guidelines, corporate compliance guidelines and corporate programs. •Creating high quality regulatory reports for submission within assigned timelines. •Evaluate and escalate potential safety issues to management. •Participated in training sessions and develop skills on a continuous basis.