Dr. Narayan Tripathi Email & Phone Number

India

Gurgaon, Haryana, India

• Participating in RA inspections, CAPA and Deviation management.
• Responsible for maintaining global PV compliance for ICSR and Risk management activities
• Inspection readiness: Maintaining PV compliance for global follow up activity, RMP commitments, SDEA compliance, P & L configuration and literature monitoring list
• Responsible for drafting and reviewing global and regional SOPs, WPDs related to PV services
• Drafting and reviewing SDEA, SMP, Country PV affiliates training calendar
• Conduct stand-up review meetings to identify gaps, challenges every day to ensure compliance to regulatory timelines

Gurgaon, India

• Performing validity, triaging and duplicate search of ICSRs received from different sources.
• Medical review of ICSRs& clinical trial SAEs/Pregnancy Exposure cases entered in Argus Safety.
• Performing medical coding of events, indications, historical conditions, current conditions, medical procedures, laboratory data and laboratory tests per MedDRA (WHO medical dictionary).
• Perform quality review of ICSRs (literature, spontaneous, regulatory authority, market research program, other study reports, post marketing studies, and registry cases) in Argus safety database.
• Causality assessment of unexpected case occurrences/ SDRs drafting of molecule specific evaluation reports.
• Reviewing safety data processed in Argus safety database for the timely reporting of expedited reports for marketed products to different regulatory authorities such as DCGI, EMEA, US FDA, Health Canada, ANVISA, BfArM.

Gurgaon, India

• Project ECHO: Identifying access model options, respective business cases and target constituencies for pilot in India (Breast cancer access to health programs for rural and semi-urban India)
• Mapping and engaging strategic stakeholders & influencers (including government authorities) by assessing their POVs for doing requirement analysis to implement data reporting and analysis portal for the pilot program
• Proposed pilot options with business cases by using appropriate statistical models for data gathering, analysis and scalability
• Managed case processing by Case Registry (Triage), Case Processing, Quality Review of cases for submission to Regulatory Authorities in EEA and FDA in ARGUS database.
• Subject matter expert for product quality complaints and liaise with center level elite compliance team (700+ staff)
• Devise strategies for post-marketing surveillance projects of 140+ pharmaceutical products with market value of $15MM marketed across 50+ countries

New Delhi Area, India

• In depth knowledge and use of the Pharmacovigilance database ARISg and ARGUS for processing of Adverse Events and Adverse Drug Reactions for Post-marketing cases (Spontaneous, CIOMS, E2B XML reports, ASPRs and.
• Knowledge of Pharmacovigilance guidelines and regulatory requirements (EMEA and FDA).
• Detailed knowledge of medical coding, currently as per MedDRA (Medical Dictionary for Drug Regulatory Activities).
• Quality inspection of various spontaneous, solicited and literature adverse event cases including Intrauterine exposure reports, Medical devices reports, Medication errors reports etc, from Health Care professionals.
• Review the triaging of AE and ADR cases prepared by the agents as per their seriousness, causality, reportability etc.
• Perform initial checks and search database to prevent duplicate entries of the cases.

Bengaluru Area, India

• Obtain and process adverse event (AE) data obtained in clinical trials and/or post-marketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements
• Mentor new project leads.
• Quality review of ICSR.
• Process the adverse event data for post market projects and clinical trials according to the company regulations, Guidelines (GDLs) Standard Operating Procedures (SOPs), and project requirements.
• Data base searches as necessary for duplicate ICSRs. Case triage and registry, MedDRA coding of the Reported Reaction Term (RRT), causality assessment, labeling of the RRT (serious/non serious) and ICSR narrative.
• Literature searches to identify adverse events for inclusion in the worldwide safety database.

New Delhi Area, India

Expertly performed routine dental procedures including Oral prophylaxis, Restoration, RCT, Surgical extraction, Crown Preparation, RPD, FPD, Dental Implants. Also provided patient counselling and clinic management.

Bds, Dentistry, First Class

Activities and Societies: Gold Medalist SG Memorial Award 2010 Best out going Student 2010

12Th Grade, First Class