Summary
Overview
Work History
Education
Skills
Performance Highlights
Key Skills
Websites
Timeline
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Dattaram Raikar

Dattaram Raikar

Bangalore

Summary

Accomplished pharmacovigilance expert with over a decade of experience in drug safety operations and regulatory intelligence. Demonstrated success in leading high-performing teams and overseeing comprehensive ICSR processing across diverse report types, including pharmaceuticals, medical devices, and cosmetics, showcasing strong proficiency in MedDRA coding and safety database operations (Argus Safety, Clinevo Safety). Proficient in narrative writing, quality review, training and mentoring, and CAPA management, driving operational excellence and compliance while ensuring timely and accurate safety reporting in accordance with Good Pharmacovigilance Practices (GVP), ICH guidelines, and international regulatory standards.

Overview

11
11
years of professional experience

Work History

Pharmacovigilance Specialist

ClinChoice India Pvt Ltd
Bangalore
06.2020 - Current
  • Led and managed a high-performing team, ensuring operational efficiency and delivery of pharmacovigilance activities to global standards.
  • Oversaw end-to-end management of ICSRs across pharmaceuticals, medical devices, and cosmetics, covering spontaneous, clinical trial, literature, and regulatory authority reports.
  • Delegated tasks, allocated resources effectively, and ensured deliverables were met within committed timelines.
  • Monitored follow-up queries, provided expert guidance to the team, and ensured accurate safety database documentation as per applicable procedures.
  • Provided timely feedback to associates, documented errors, and conducted error trend analyses, leading to effective remedial actions.
  • Maintained 100% audit- and inspection-ready documentation, ensuring compliance with global regulatory requirements.
  • Mentored and onboarded new joiners, achieving full integration within 3 weeks.
  • Performed initial incident reportability assessments and prepared regulatory submissions to competent authorities.
  • Managed documentation in appropriate trackers, ensuring accuracy and accessibility.
  • Conducted IQC-based error trend analysis, implementing process improvements that reduced case processing time from 2 hours 30 minutes to 1 hour 45 minutes.
  • Managed the reconciliation process across multiple stakeholders.
  • Contributed to User Acceptance Testing (UAT) for PV systems and process updates.
  • Actively participated in ANSM and MHRA audits, helping clients achieve zero findings.
  • Handled case exchanges with partners, affiliates, and service providers, ensuring timely submissions in accordance with SDEA agreements.

Senior Drug Safety Associate

BioClinica India Pvt Ltd
Mysore
01.2019 - 06.2020
  • Enter and code case data, including events, seriousness, reported causality (when appropriate), medical history, and laboratory data, ensuring accuracy and completeness.
  • Correct data entry errors prior to routing cases in the global safety database.
  • Code products specified as suspect or concomitant using Company Drug Dictionary (CDD) and WHO Drug Dictionary (WHO-DD).
  • Perform medical coding of adverse events, medical history, and laboratory data using MedDRA terminology.
  • Write medically relevant case narratives and perform listedness assessments in accordance with regulatory and company requirements.
  • Peer review cases for accuracy, consistency, and completeness against source documents, ensuring narrative alignment, data integrity, and documentation of delays when applicable.
  • Assess cases for reportability and ensure compliance with E2B standards.
  • Mentor and guide new hires, supporting onboarding and skill development.

Drug Safety Associate

Tata Consultancy Services (TCS)
Mumbai
07.2014 - 11.2018
  • Case processing of spontaneous, solicited, and non-interventional study reports.
  • Evaluation of serious adverse events using IME.
  • Ensure accurate and consistent data entry and processing from source documents with emphasis on timelines and quality.
  • Writing case narratives and assessing the expectedness or listedness of adverse events.
  • Involved in emergency unblinding process (Unblinding of patient on request).

Education

M- Pharmacy - Pharmacology

KLE’s college of pharmacy
Hubli, Karnataka
06.2013

B-Pharmacy - Pharmacy

KLE’s college of pharmacy
Hubli, Karnataka
08.2010

Skills

  • Leadership & Quality Management
  • ICSR Handling & Managing
  • Safety Data Reconciliation
  • Global Safety Reporting Requirements
  • Safety Database & Tools (Argus Safety, Clinevo Safety and Microsoft Office Suite) Process Improvement
  • Regulatory intelligence
  • Cross-functional Collaboration

Performance Highlights

  • 100% Regulatory Compliance
  • Reduced case processing time
  • Quality Scores 98%+
  • Workflow Efficiency Improvement
  • Error Reduction through CAPA Implementation
  • Successful Audit & Inspection Outcomes

Key Skills

  • Leadership and quality management
  • ICSR handling and managing
  • Safety data reconciliation
  • Global safety reporting requirements
  • Safety database and tools (Argus Safety, Clinevo Safety, and Microsoft Office Suite)
  • Regulatory intelligence
  • Cross-functional collaboration

Timeline

Pharmacovigilance Specialist

ClinChoice India Pvt Ltd
06.2020 - Current

Senior Drug Safety Associate

BioClinica India Pvt Ltd
01.2019 - 06.2020

Drug Safety Associate

Tata Consultancy Services (TCS)
07.2014 - 11.2018

M- Pharmacy - Pharmacology

KLE’s college of pharmacy

B-Pharmacy - Pharmacy

KLE’s college of pharmacy

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