Garima Sabharwal
Senior Patient Safety Specialist at PAREXEL
- Role
- Senior Patient Safety Specialist at Parexel
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Garima Sabharwal
More than 8 years of experience in Pharmacovigilance including triage, data entry, validation, and quality review of Individual Case Safety Reports (ICSRs) coming from Global ICSR Automation tool. Expertise in management of ICSRs of various case types (spontaneous, clinical studies, vaccines and solicited programs). Subject Matter Expert, Point of contact (POC) for the Client for the User Acceptance Testing (UAT) for the Global Automation ICSR tool and Mentoring coordinator for the training of new recruits in the team. Familiar with international drug safety regulations (including International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on safety and efficacy, United States Food and Drug Administration (FDA) guidelines, Council for International Organizations of Medical Sciences (CIOMS) and European Union Good-Pharmacovigilance Practice (EU GVP) guidelines).
Experience
Senior Patient Safety Specialist
Nov 2025 — Present · Bengaluru, IN
Subject Matter Expert and providing support in the inspections and audits.• POC for the Client in UAT for the Global Automation ICSR.• POC for Database Migration of a Newly Acquired Pharmaceutical Company by the Client for the Global Automation ICSR tool.• Expertise in handling VEEVA Vault RIM.• Mentoring coordinator for training of the new recruits in the team. Responsible for overall planning and implementation of the mentoring process with the proper training materials and plan for the team.• Pilot project for Quality Improvement plan: SME check of the cases randomly for the users in the team to help increase the overall quality and compliance.• Expertise in management of ICSRs of all case types (spontaneous, clinical studies, vaccines and solicited programs), coming from Global ICSR Automation tool.• Handling the compliance matrix and generating the reports and responsible for maintaining the KPIs.• Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs coming from Global ICSR Automation tool in accordance with clients’ policies and requirements.• Expertise in referring the Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures, and international drug safety regulations.• Expertise in global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.• Expertise in handling the ERP systems.
Education
Maharishi Markandeshwar (Deemed to be University) Official
BDS, Dentistry
2012 — 2017
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