Pradeep Tambe

Experience

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  USV PRIVATE LIMITED

  Jul 2012 - Jul 2013

  SALES

  · Successfully contributed in growth of the organization by exceeding the expected targets in consecutive quarters.· Understanding pharmaceutical market and increasing the sales of the assigned products.· Successfully launched different products and achieved top position in terms of revenue in the pharmaceutical market.· Qualified for a foreign tour based on yearly turnover of assigned territory. · Successfully coordinated between stockist and retailers for availability of the medicines to avoid out of stock situation. Show less

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  Cognizant

  Aug 2013 - Sept 2015

  Junior Data Analyst

  · Performed roles of ICSR Data Entry (DE), Quality Control (QC) and Pharmacovigilance compliance officer.· Successfully completed transition of blockbuster products as part of 5 member pilot batch team.· Established a team of 35 members starting from 5 members.· To conduct huddles for the team on new updates. · In depth knowledge of coding principles with the help of MedDRA.· Triaging of cases received for processing.· Allocation of cases to team members. · Responsible for prioritizing cases for processing and transfer for medical review.· Help to ensure the development, effectiveness evaluations and compliance with PV SOPs.· Support the design, development & maintenance of CAPA management and monitoring of trends with proposed remediation actions.· Provide quality, training, and compliance activity to support the company, when needed. Show less

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  Sciformix

  Sept 2015 - Nov 2016

  Safety Data Analyst

  · Worked onsite at Client location in Hyderabad leading a team of 12 members as a subject matter expert and workflow lead.· Processing of ICSR and route serious cases for medical review and locking.· Performing quality check of serious and non-serious Individual Case Safety Report.· Coding of adverse events with the help of MedDRA.· Triaging of cases received for processing.· Conducting team huddles for process related updates to the team.· Maintaining the documentation for adherence of compliance to the organizational and client specific training.· Evaluate and complete processing of AE reports, including review for completeness and accuracy.· Use medical dictionaries and business guidance to code medical history, drugs and adverse event terminologies. Prepare narratives summarizing the essential details of the case.· Identify clinically relevant information missing from a case report and facilitate its collection (in consultation with medical reviewer as required) by preparing follow-up request as needed.· Alert manager to potential safety signals based upon incoming case reports.· Work with country safety departments, license partners, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and data based. Show less

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  IQVIA

  Dec 2016 - Nov 2018

  · Leading a team of 16 members who are responsible for timely submission of reports to health authority.· Allocation of cases to the team members and prioritizing cases as per SLA and regulatory requirements.· Deviation management which include identifying root cause and providing corrective action as well as preventive action and documenting same for audit purpose.· Participated in internal audits with evidence based approach and to determine conformance to planned arrangements.· Closure of nonconformance report received during external audits.· Established a team of 5 members for conducting follow up with the physician and addressing action items which helped in time saving for case processors resulting in improved quality and productivity.· Subject matter expert (SME) during pilot phase of automation in Pharmacovigilance.· SME for pharmaceutical products as a clinical safety scientist in Pharmacovigilance.· Quality review of cases for submission to health authority as per regulatory guidelines.· Conducting training to the team on timely basis related to process improvement. Show less

  • Team Lead

    Jun 2018 - Nov 2018

  • Operations Specialist 1

    Dec 2016 - May 2018
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  Accenture

  Dec 2018 - Sept 2020

  Risk and Compliance Lead Auditor

  Develop Audit Schedule for calendar year in agreement with QA and operational management. Schedule and conduct audits, release / draft audit report, approve CAPA responses and track CAPA actions to closure. Monitor compliance to the audit schedule.Performed Internal Audits as per scope and agenda including remote audits for projects delivering services at Prague, Nuremberg, Osaka, Tokyo and Dalian. Provide consultation for managing internal, sponsor or regulatory issues/deviations. Managed Due Diligence Audit for prospective clients. Provided consultation support and guidance during client audit / regulatory inspections and support in performing RCA and drafting CAPA responses for regulatory inspections / client audits.Ensure timely closure of CAPAs for regulatory inspections / client audits; highlight risks and take appropriate actions (as required) in consultation with management.Implement/comply QMS procedures as per requirement specified in the Quality Manual, applicable organizational policies and SOPs/SWIs/Guidance documents. Develop/review SOP/SWI/Guidance documents in line with client procedures and regulatory requirements.Manage, track deviations/issues in compliance with the applicable procedural documents. Support in performing RCA, review and confirm completeness of documentation.Review the CSV documented evidences (Installation Qualification (IQ) test scripts, Operational Qualification (OQ) test scripts, Performance Qualification (PQ) test scripts) for the internally developed tools during the internal audit to confirm that the user needs, intended uses and particular requirement implemented through software can be consistently fulfilled.Assess potential risk and immediate actions required through risk assessment tool for compliance oversight for all the capabilities/projects. Show less

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  Labcorp

  Oct 2020 - now

  Experienced in conducting Internal Process Audits and Contracted Project Audits. Process audits include Pharmacovigilance audits (Clinical and Post-Marketing), Medical Monitoring, Biostatistics/ Statistical Programming and Clinical Operations. Contracted Project Audits include Trial Master File (TMF) and Clinical Study Report (CSR) Audit.

  • Associate Manager GCP-QA

    Aug 2022 - now

  • Assistant Manager, GCP Auditor

    Oct 2020 - Jul 2022