Haritha Napa
London,United Kingdom
Summary
Experienced Pharmacovigilance Professional with a keen eye for detail and knack for improving drug safety protocols. Known for enhancing compliance and ensuring patient safety through thorough data analysis and risk assessment. Proven ability to collaborate with cross-functional teams to implement robust safety protocols. Known for fostering collaborative environments and driving continuous process improvements.
Overview
6
6
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work history
Pharmacovigilance Associate / Drug Safety Associate
ICON Clinical Research Pvt Ltd
Chennai, India
03.2021 - 02.2024
- Processed Study-specific Clinical Trial (Phase I-III) and Post-Marketing Surveillance cases (including Social media and Literature), ensuring data integrity and global regulatory compliance.
- Conducted SAE reconciliation, managed case-related queries, and case follow-up activities effectively.
- Handled medical information received from diverse sources.
- Executed safety inbox management activities for various projects.
- Performed quality control, adverse event assessment, MedDRA coding, and regulatory submissions to MHRA, EMA, FDA, and Health Canada.
- Supported signal detection activities and contributed to comprehensive risk management documentation.
- Trained in medical device case processing, expanding safety surveillance expertise across therapeutic areas.
- Participated in Root Cause Analysis, implementing CAPA initiatives, and preparing for internal/external audits.
- Led migration study projects while training junior team members on Pharmacovigilance processes.
Drug Safety Associate
Accenture Solutions Pvt Ltd
Chennai, India
03.2019 - 03.2021
- Processed Global/ Health Authority cases and (Spontaneous and Solicited) in accordance with international regulatory timelines.
- Contributed significantly to the successful completion of the case correction project, enhancing quality metrics.
- Reviewed and coded adverse events using MedDRA; labelled events through Trackwise, Product monograph, and CCDS.
- Executed regulatory submissions for the FDA, EMA, and Health Canada. Handled the project safety mailbox.
- Collaborated with medical reviewers to ensure precise clinical assessment of cases.
Intern
District Head Quarters Government General Hospital
Chittoor, India
03.2018 - 03.2019
- Completed a one-year internship in compliance with Pharm D regulations from the Pharmacy Council of India.
- Participated in daily ward rounds with physicians and healthcare teams.
- Conducted patient counselling on medication use and lifestyle changes.
- Monitored Adverse Drug Reactions (ADRs) to ensure patient safety.
- Executed drug interaction checks, prescription audits, and analysed medication errors.
- Assisted in therapeutic drug monitoring and adjusted doses based on clinical findings.
- Prepared and presented case studies and drug information reports to medical staff.
- Developed educational materials for chronic disease management, including diabetes, hypertension, and asthma.
Education
Doctor of Pharmacy - Pharmaceutical Sciences
Sri Venkateswara College of Pharmacy
Chittoor, Andhra Pradesh 09.2013 - 03.2019
Skills
- Pharmacovigilance databases expertise (ARGUS Safety, Aris Global, Medidata- RAVE, Inform Essentials, AgX, PV case management module)
- SAE reconciliation
- End-to-end ICSR case processing
- Narrative writing
- Quality assurance
- MedDRA coding
- ICH-GCP compliance
- GVP guidelines knowledge
- Adverse event labeling
- Audit support and preparation
- Signal detection
- Query formulation
- Regulatory submissions expertise
- Clinical research methodologies
Project & Publications
- Contribution of Various Factors in the Inverse Relationship of Alzheimer's Disease and Cancer, International Journal of Pharmacy and Therapeutics, 2017, 8, 4, 147-152
- A prospective study on monitoring efficacy of antipsychotics in patients with psychosis, International Journal of Novel Trends in Pharmaceutical Sciences, 2018, 8, 4, 80-87
Certification
- Signal detection and Causality Assessment by UMC in Dec 2017.
- SCOPE: ADRs- Reporting makes medicines safer by the MHRA (UK) in July 2018.
- Vaccine Safety Basics by the WHO e-learning course in September 2018.
- Statistical reasoning and algorithms in Pharmacovigilance by UMC in Feb 2019.
- Health and Safety Well-being - Infectious Diseases by Alison Learnings in September 2025.
- Professional Affiliations- Registered Pharmacist (RPh), Pharmacy Council of India (PCI), 4935.
Timeline
Pharmacovigilance Associate / Drug Safety Associate
ICON Clinical Research Pvt Ltd
03.2021 - 02.2024
Drug Safety Associate
Accenture Solutions Pvt Ltd
03.2019 - 03.2021
Intern
District Head Quarters Government General Hospital
03.2018 - 03.2019
Doctor of Pharmacy - Pharmaceutical Sciences
Sri Venkateswara College of Pharmacy
09.2013 - 03.2019
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