Tarunkumar Rana PSM I, PMP®, PgMP®

Experience

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  Drug Testing Laboratory (CADRAT), JSSCP, Ooty

  Mar 2011 - Feb 2012

  Project Assistance

  Formulation & Development for TABLET (from pre-formulation studies to Tablet Punching)

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  Tata Consultancy Services

  Jun 2012 - Mar 2017

  Business Process Lead

  • Assessed seriousness, causality, and labelling of serious adverse events and performed quality checks on ICSRs, including clinical, spontaneous, PMS, E2B, RAVE, legal, literature, and CIOMS, to ensure accurate and consistent data entry in ARISg from source documents.• Provided timely alerts to Medical Safety Physicians regarding potential safety issues and supported them in monitoring the safety profile of products.• Collaborated with the Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases, meeting joint accountabilities and enabling the locking of the Clinical database.• Conducted monthly quality feedback and refresher sessions for the case processing team, providing updates on current SOPs, managing ICSR case processing queries, and identifying areas of improvement.• Mentored new DSA members on ICSR case processing and quality checks.• Supported Health Authorities’ inspections and audits, and participated in the preparation of RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Actions).• Ensured case validity by checking and initiating valid cases for further processing.• Handled case processing for clinical, non-interventional programs, and spontaneous cases.• Managed legal case processing, including summons, fact sheets, and medical records.• Wrote narratives for ICSRs, assessed event seriousness and expectedness, and captured valid event terms to link with the current MedDRA term. Show less

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  SUN PHARMA

  Mar 2017 - Dec 2023

  Senior Executive

  Project Management - Formulation Development (Jun 2020 to Dec 2023)• Collaborated with stakeholders to gather project requirements, documenting them through spreadsheets, diagrams, and process maps.• Managed projects from feasibility to patent assessment, overseeing procurement, development timelines, clinical studies, and manufacturing coordination.• Monitored regulatory team activities for dossier compilation and filing deadlines.• Conducted regular project reviews, identified bottlenecks, and ensured day-to-day operations.• Created project plans, led project planning, and facilitated the definition of project scope and deliverables.• Collaborated with the Project Management Office to assess human capital needs and update methodologies.• Ensured overall project governance and compliance with industry regulations.• Tracked timelines, deliverables, and budgets, assessing risks and proactively resolving issues.• Managed changes to project scope, schedule, and expenditures, reporting issues to senior management.• Maintained awareness of potential interdependencies with other projects.Global Pharmacovigilance (Mar 2017 to May 2020)• Coordinated between country safety leads and the PV function team, serving as the single point of contact.• Conducted quality reviews of various ICSRs to ensure compliance.• Authored Periodic Adverse Drug Experience Reports (PADER) and PSURs.• Analyzed quality trends and published Quality Metrics using tools like Pareto charts and Control charts.• Submitted Expedited ADR reports to regulatory agencies such as USFDA, Health Canada, and the Ministry of Health in Israel.• Prepared and reviewed SOPs and WPDs for case processing and case validity assessment.• Provided CAPA responses using tools such as Fishbone or Ishikawa diagrams.• Conducted global literature monitoring and prepared Cumulative Summary Tabulations of Serious Adverse Events. Show less

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  Syngene International Limited

  Dec 2023 - now

  Associate Manager – Global Program Office