Vived Kumar Turai Email & Phone Number

Frankfurt Am Main, Hesse, Germany

Mannheim, Baden-Württemberg

Mannheim, Baden-Württemberg, Germany

Role & Responsibilities: Lead DSA• Setup of the safety services.• Assist with the preparation of Aggregate safety reporting plan and data listings required for the signal detection. • Lead and coordinate the planning, organization and forecasting of requirements and/or resources based on workflow and other upcoming tasks and activities.• Triage, process and performing quality review of the reports received under tighter time lines with high quality.• Assigning… Show more Role & Responsibilities: Lead DSA• Setup of the safety services.• Assist with the preparation of Aggregate safety reporting plan and data listings required for the signal detection. • Lead and coordinate the planning, organization and forecasting of requirements and/or resources based on workflow and other upcoming tasks and activities.• Triage, process and performing quality review of the reports received under tighter time lines with high quality.• Assigning, tracking and reconciling of the reports processed, Follow-up requests for reported adverse reactions.• Train and mentor the new associates.• Assist in the reconciliation of clinical and safety databases.• Prepare and author Safety Management Plan (SMP), reporting requirements, SAE form guidelines in accordance to the protocol. • Submissions of the SUSARs/DSURs/Line listings to the Ethics Committees (ECs), Investigator sites and Regulatory authorities with applicable reporting requirements within strict timelines. Show less

Bangalore, India

Individual Case Safety Report (ICSR) Processing – Post Marketing SurveillanceResponsibilities:• Receive, triage, review and process pharmacovigilance data from various sources on time and quality standards. • Perform data entry for tracking and pharmacovigilance databases, coding relevant medical terminology by using MedDRA, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure… Show more Individual Case Safety Report (ICSR) Processing – Post Marketing SurveillanceResponsibilities:• Receive, triage, review and process pharmacovigilance data from various sources on time and quality standards. • Perform data entry for tracking and pharmacovigilance databases, coding relevant medical terminology by using MedDRA, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. • Assess pharmacovigilance data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight.Individual Case Safety Report (ICSR) Processing – Clinical Trails• Triage and process clinical, initial and updated safety data, reviewing safety data for inconsistencies, contacting sites with queries as needed, ensuring safety data is corrected by site staff, entering applicable safety data into a serious adverse event (SAE) database when needed.• Writing narratives; coding terms, as appropriate; ensuring initial reports are sent to customers or marketing authorization holders within agreed timelines; updating narratives when updated information is received, as appropriate liaising with customer/marketing authorization holders, executing case closure, reconciliation and preparation of events for archiving. Show less

Hyderabad

• Screening the subjects, enroll the subjects based on inclusion criteria, assist the Principal Investigator in informed consent process, conduct lab investigations, maintain temperature logs for the study drugs, accountability of study drugs, dispense study drugs, patient counseling, educating the subject about the drug, its side effects, precautions to be taken when an AE(Adverse event) occurs.• Schedule visits, conduct lab investigations as per the visits, collect the samples and send… Show more • Screening the subjects, enroll the subjects based on inclusion criteria, assist the Principal Investigator in informed consent process, conduct lab investigations, maintain temperature logs for the study drugs, accountability of study drugs, dispense study drugs, patient counseling, educating the subject about the drug, its side effects, precautions to be taken when an AE(Adverse event) occurs.• Schedule visits, conduct lab investigations as per the visits, collect the samples and send them to the central lab for few blinded lab investigations, prepare source notes, data entry into electronic Case Report form (eCRF), answering queries raised in eCRF, co-ordinate between CRO and Hospital ethics committee, report SAE(Serious Adverse Event) to Institutional ethics committee, CRO & other regulatory agencies as per the requirement Show less

Hyderabad, Telangana, India

• Active ward round participation with physicians on a daily basis.• Prescription check for potential drug interactions.• Answering Drug information Queries.• Patient counseling.