Gorakshanath Kakde

Training Lead-Aug/2025-Current

• Design and deliver comprehensive training programs for new and existing executives.
• Develop and facilitate ongoing training sessions on client product knowledge, techniques, and customer service best practices.
• Identify skill gaps and create targeted training initiatives to address them, improving overall team performance.
• Stay updated with industry trends and incorporate best practices into training programs.
• Track training records, Training file, audit readiness and analyze training effectiveness and make data-driven improvements.
• Generate and maintain quality assurance reports to track team performance over time and share them with the TLs.

ICSR Team Lead -Jan/2023 -Jul/2025

• Recommend process enhancements and best practices to optimize presales efficiency and customer walk-ins.
• Lead pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.
• Act as workflow manager to allocate and distribution of ICSR report to case processing team.
• Maintained regulatory compliance and supported cross-functional safety teams
• Oversee the collection assessment and reporting of adverse event data to maintain patient safety.
• Provide expert guidance on pharmacovigilance processes and ensure timely case processing.
• Collaborate with cross-functional teams to enhance safety operations and improve efficiency.
• Utilize MS Excel, power query, G-sheet to analyze data and generate reports for stakeholders.
• Accountable for proactive workload management within their teams and across the function to ensure that internal/licensee and regulatory timelines are met.
• Collaborating with other Team Leaders, Group Leaders, Associate Project Managers, Project Managers and Vendor Management Group to discuss workload and proposed solutions to fluctuating workload as needed.
• Initiated and managed pharmacovigilance agreements and clinical reporting workflows
• Provided mentorship, conducted audits, and maintained performance metrics
• Led global aggregate safety reports and literature surveillance activities
• Actively participate in project team and client meetings and liaise with clients.
• Maintaining, monitoring and tracking records relating to training, productivity, compliance and quality of Drug Safety teams.
• Develop and implement strategies to optimize pharmacovigilance workflows.
• Engage with external partners to align on safety standards and practices.
• Contribute to the continuous improvement of pharmacovigilance systems and tools.
• Participate in audits and inspections to ensure compliance with industry regulations.
• Supervised day-to-day operations to meet performance, quality and service expectations.
• Defined clear targets and objectives and communicated to other team members.
• Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
• Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
• Manage data reconciliation activities to ensure accuracy and completeness of clinical trial data.
• Develop and implement effective data management plans, including database lock procedures.
• Collaborate with cross-functional teams to resolve issues related to query management and UAT (User Acceptance Testing).
• Conduct regular listing reviews to maintain high-quality datasets.
• Ensure compliance with regulatory requirements throughout the entire lifecycle of a clinical trial.
• Develop and manage project plans, including spend, resourcing and deliverables to design, configure, and develop Quality solutions using technologies
• Ensure compliance to GVP, deployment standards and quality guidelines with regulatory related obligations are executed with the highest standards of compliance
• Support testing and other activities necessary

• Supervised case processing teams and coordinated with clients
• Reviewed SOPs, handled Argus database entries, and submitted SUSARs
• Managed PV audits, CAPA closure, and compliance documentation
• Update and maintenance of PVA, Clinical Trial Safety Reporting procedures (CTSRPs) and Allocated Country Responsibility Document (ACRD).
• Management of PVA/SDEA mailbox.
• Work on and Clinical Trial Safety Reporting procedures (CTSRP) updates.
• Work on management of PVA and CTSRP signature process via DocuSign.
• Drafting and publication of CTSRP termination and Letter of intent.
• Monitoring and maintaining the status update of all agreements and ongoing work in PVA database.
• Coordination and discussion with external and internal stakeholders for PVA/SDEA related activities.
• Work on updates for supporting documents (covering territories and products)
• Quality review of performed activities
• Provide list of agreements to support generation of the PSMF when required.
• Tracked project and team member performance closely to quickly intervene in mistakes or delays.

• Managed case submissions to EMA EVPM, FDA, Health Canada
• Performed expedited reporting, SAE reconciliations, and quality reviews
• Conducted training and process compliance checks
• Collaborated with other departments to integrate safety in all aspects of organization.
• Investigated accidents and incidents to determine root causes and develop corrective actions to address underlying issues.
• Identified patterns and trends in large data sets and provided actionable insights.

• Triaged literature, processed ICSRs, and authored narratives
• Handled MedDRA & WHODD coding using ARGUS and ARISG
• Working as mailbox reviewer, Case Intake, Review, Triage, Date Entry, Reportability Assessment & E2B transmission
• ICSR classification and processing of clinical, spontaneous, post-marketing survey and E2B cases.
• • Initial check of adverse event forms, duplicate search, and determine case criteria.
• • Create a unique number in the Safety database Argus and ARISG and maintain track in the tracking tool. Determine seriousness, the validity of cases, adverse event term, ranking, and expectedness/ listedness and raise urgent and non-urgent queries to safety responsible personnel for missing information.
• • Medical coding of the adverse events, indication, medical history, laboratory data using MedDRA dictionary and patient concomitant, historical and treatment medication using WHODD dictionary and suspect coding with company drug dictionary (CDD).
• • Write a brief patient narrative as per the guidance and perform self QC for a case.
• • LITERATURE REVIEW: Embase: -Primary review, Triage, and case processor. Ensure the effective and accurate, collection, recording, review and reporting of literature searches conducted. Screening and review of literature search results (articles/abstracts/citations). Responsible for full text online or through Science Direct, PubMed or any vendor and sending translation for foreign articles.

• Worked on spontaneous, litigation, and clinical trial cases
• Supported case intake, coding, narrative writing, and submission
• To perform drug safety data management, process a combination of case intake, triage, case entry, data entry, quality review, medical review, medical coding, narrative writing, case follow-up, report preparation, and submission to regulatory authorities. Types of cases handled: Serious and non-serious spontaneous, literature, litigation, E2B cases, legal cases, and clinical trial cases.
  • Worked as case processor (DE), a quality check (QR), as a medical reviewer (some marketed product), medical coder and narrative writer.
  • Performed literature review and litigation cases: Reviewed litigation cases as per legal department and mark relevant information, review initial court file (ICF), Plaintiff fact sheet (PFS) and medical record and data entry and quality review of the case as per legal cases convention.

• ICD-9/10 coding for insurance and CMS compliance
• Reviewed medical records to ensure accurate documentation
• International Classification of Disease (ICD): ICD-9, ICD-10 coding: Highly skilled in performing coder duties pertinent to ICD-9, ICD-10, BCHHC, and techniques.
• Insurance home health coding (HHC) with OASIS knowledge.
• Reviewed member medical records for providers to verify and ensure appropriate and accurate diagnosis and procedural data in compliance with Centre' for Medicare & Medicaid Services (CMS) and state-specific guidelines.
• Applied official coding conventions and rules from American Medical Association and Centers for Medicare and Medicaid Services to assign diagnostic codes.