Dr. Dinesh R.

Experience

• 

  Basaweswara Hospital

  Sept 2013 - Sept 2014

  Pharmacovigilance Intern

  Assessing the drug related problems like ADR's, Drug interactions and Dosage errors

• 

  CAPITA

  Mar 2015 - Oct 2015

  HEOR Trainee ,Health Economics and Outcome Research

  Systematic reviews, Data Extraction and Meta Analysis

• 

  Accenture in India

  Nov 2015 - Aug 2018

  As a case intake member:• Responsible for case intake, duplicate check and registration 2. Maintain log of source documentation and other communication.As a case processor:• Responsible for data entry of individual case safety report (literature cases) into the safety database.• Review and evaluate AE case information to determine required action based on and following internal policies and procedure.• Process all incoming cases in order to meet time line.• Full data entry including medical coding and safety narrative.As a medical coder:• Responsible for coding all medical history (events, procedure, suspect drugs from the article, indication, lab tests as per dictionary (MedDRA and WHO-DD).As a narrative writer:• Responsible for writing medically relevant safety narrative of cases and checking the competence and accuracy of the data entered in various fields.As a quality check reviewer:• Performing quality check of cases against the source document articles including the coding of events, coding of suspect, co-suspect and concomitant medications.• Case assignment and related activities.• Handling site related queries.• Involved in various refresher training programme to train the new employees non-Argus and drug specific conventions. Show less

  • Medical Service Analyst

    Dec 2016 - Aug 2018

  • Safety processing expert (Medical Service Associate)

    Nov 2015 - Nov 2016
• 

  IQVIA

  Aug 2018 - now

  • As a Study Manager and Study Lead, I manage client meetings and requirements, team tasks, KOM, and workflow management on a regular basis.• Monthly SAE/DD listings• Compliance reports• Safety Reconciliation reports• Study workflow metric reports• Reviewed adverse event reports to ensure accuracy and completeness of data collected.• Prepared periodic safety update reports and other documents related to regulatory submissions.• Collaborated with medical directors, clinical research associates, and regulatory affairs personnel to ensure compliance with applicable regulations and guidelines.• Provided technical support during internal audits or inspections by health authorities.• Generated metrics to measure performance of pharmacovigilance processes within the organization.• Created and maintained standard operating procedures for pharmacovigilance activities.• Developed training materials on drug/device safety topics for internal use by employees.• Drafting Project/Study related documents (SMP, Templates etc.,) • Researched emerging trends in pharmacovigilance practices and shared findings with colleagues.• Maintained a database of adverse events received from various sources including spontaneous reporting systems.• Annual reports, Quarterly reports (Writing, Review and Submission)• Argus Safety database• MedDRA and WHO-DD• Narrative writing• Client meeting and Minutes of meeting• DSMB Meetings• Medical Device and Drug case processing Show less

  • Operations Specialist Manager

    Nov 2023 - now

  • Associate Safety Manager

    Sept 2021 - Oct 2023

  • Senior Safety Specialist

    Oct 2019 - Aug 2021

  • Safety Specialist

    Aug 2018 - Sept 2019