Case processing and Quality review: Expertise in end to end data entry and quality control of safety reports of different types of cases like Legal cases, Literature cases (medical journal abstract, summary reports, full text article), Spontaneous (Regulatory authority- EVWEB E2B, MHRA, Health Canada, USFDA-MedWatch, HA China, and other health authority cases), Partner reports, Local affiliate reports, US Pure complaint, Medical device cases and Combination drugs reports, Internet and digital media cases, and Solicited reports from post market survey/studies/programs (Non-interventional study, Non-interventional program like Patient support program or patient access program, registry cases, REMS programs, etc., into the safety database Argus.Data entry of the patient data, suspect and concomitant drugs, selection and detailing of adverse events, action taken, de-challenge and rechallenge, seriousness, medical, and causality assessment.Assessing upgrading or downgrading of case also performing deletion and nullification of case.Coding all medical history, events, drugs/procedures/indication and laboratory tests according to the appropriate dictionary (MedDRA, Company Product Dictionary, WHO drug dictionary).Assessing labelling of adverse events using reference safety information documents (CCDS, SmPC, USPI). Meeting the timelines and supporting global regulatory submissions in expedited reporting ofICSR. Following client specified SOP’s and meeting deadlines.Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.Maintained a good working knowledge of safety profile of assigned drugs, RSI documents, client conventions, guidelines, procedures, and drug safety regulation.Maintained an awareness of global regulatory reporting obligations and organized workload to ensure compliance with internal and regulatory timelines

Case processing:Responsible for data entry of individual case safety reports into the safety database ArisG. Review and evaluate adverse events case information to determine required action based on following internal policies and procedures. Process all incoming cases to meet timelines. Full data entry including medical coding and medically cohesive narrative writing.Processing of different types of cases like spontaneous (partner reports, Health authority cases (Health Canada, EMA-Eudravigilance L2A cases, USFDA-MedWatch, Health authority of China), social media cases, other manufacturer cases), LPM reports, Solicited reports (PAP/PSP, NIS)Mentoring and training: Trained new team members with overall good quality and medical accuracy on safety data processing within timelines.

Worked as faculty for Pharmaceutical Organic Chemistry, Biochemistry and Clinical Pathology, and Pharmaceutical Jurisprudence.Used diverse teaching methods, including lectures, presentations, and class activities to deliver curriculum.Marked and graded homework, assignments, papers, and tests, providing constructive feedback to improve learning development.Developed tests and materials to assess and promote student learning objectives.

Book-In and Triage:Responsible for case intake, duplicate check, and registration into the safety database agXchange IRT.Maintain log of source documents and other communications. Review, Assess, Triage, Process and Report the adverse event reports according to applicable regulations, guidelines, SOP’s, and project requirements within the specified timelines by meeting the quality standards. Expertise in performing duplicate search using different parameters based on report type.Case processing:Processing of different types of cases like spontaneous (partner reports, Health authority cases (Health Canada, EMA-Eudravigilance L2A cases, USFDA-MedWatch), social media cases, other manufacturer cases, Affiliate reports), Solicited (NIP, NIS), Clinical reports (RAVE, PD55). Responsible for checking the workflows and maintaining TAT of cases assigned to fellow associates. Attend project team meetings and client calls related to the project and perform other duties as assigned like data pulling, distribution, etc.