Subham Mandal

Background

About Subham Mandal

My total experience so far is 7.4 years and I have 6 year and 7 months relevant experience as Drug Device and Vaccine safety associate. Previously in Cognizant Technology Solutions. Currently I am working at IQVIA as Operations Specialist 1 (Joined in May 2021).I have keen knowledge about: both Data Entry and Quality Review for: °Solicited study cases°Spontaneous cases°PMS cases°Literature cases°CT (spontaneous) case°Narrative writing °Event and Drug coding (Suspect and Concomitant) °HCP and NON-HCP Letter generation°Monitoring follow-up activities°Monitoring adverse events of special interest°Both E2B and Non-E2B cases I have keen knowledge on Medical coding and Argus database.Goals & Responsibility:1. Ensured regulatory compliance for individual expedited cases and case report submissions to Health Authorities or other receivers as appropriate. Accepted E2B cases received through Argus Electronic Submission Module (ESM) as necessary.2. Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA and worked closely with the coding department.3. Wrote narratives summarizing the events according to departmental SOPs for spontaneous and literature cases through assessment of all source documents.4. Utilized medical terminology, MedDRA coding terms and obtained detailed information in prevention of quality assurance discrepancies.5. Prepared narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases.6. Coding relevant medical terminology, composed descriptive narrative and generated advanced condition queries.7. Reviewed spontaneous case reports concerning adverse events and serious adverse events to ensure accurate data capture according to departmental SOPs.9. Trained and mentored new drug safety associates, providing supervision and teaching key skills in Drug Safety.10. Requested follow-up information concerning adverse event reports as appropriate11. Triaged and analyzed adverse event information for entry into the adverse event tracking and reporting system12. In-depth knowledge of US and ICH safety reporting regulations and guidelines13. Remarkable knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information14. Remarkable knowledge of scientific terms and medical terminology15. Basic understanding of FDA & international regulations16. Proficient in data entry and drug safety database