Geetanjali Kumari
Senior Drug Safety Specialist
Mohali
Summary
With 11 years of experience in Pharmacovigilance, I have developed expertise in triage, data entry, quality control, and medical and regulatory assessment of safety information. Throughout my career, I have successfully managed individual case safety reports (ICSRs) across various case types, including spontaneous, clinical studies, and solicited programs cases. A key part of my role has involved training and mentoring PV scientists in case processing activities. I am committed to upholding regulatory compliance and ensuring patient safety by strictly following international drug safety regulations, such as the International Council for Harmonisation 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.
Overview
12
12
years of professional experience
Work History
Senior Drug Safety Specialist
PAREXEL International Services India Private Limited
04.2024 - Current
- Performed QA analysis and error trending
- Involved in internal review of ICSRs at different workflows
- Involved in the tracking of quality findings and metrics against defined KPIs
- Trained with hands-on experience in Life Sphere Multi Vigilance database (LSMV), LSR for case processing activities in validation and production environment
- Provided client-specific trainings
- Designated as Subject Matter Expert for the team, providing guidance and support to colleagues on various aspects of the ICSR processing workflow
- Submission expertise to different HAs & license partners and distribution to local affiliates
Drug Safety Specialist
PAREXEL International Services (India) Private Limited
07.2020 - 03.2024
- Monitoring the compliance by monitoring the standardized ICSR lateness reasons an associated
- Corrective and Preventive Action (CAPA) plans, as applicable
- Quality experience Performing quality checks of ICSRs to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements
- Maintaining a good working knowledge of the data capture conventions and guidelines and client procedures
- Ensuring compliance of client ICSRs with company and regulatory requirements
- Highlighting any issues emerging from the QC results to the Project Manager/Senior Management
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
- Maintaining quality metrics per client requirements, as applicable
Pharmacovigilance Specialist
Parexel International Services India Private Limited
11.2017 - 06.2020
- Maintained a good working knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including ICH guidelines on safety and efficacy FDA guidelines CIOMS New EU PV legislation GVP Guidelines
- Maintained awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Pharmacovigilance Analyst
Parexel International Services India Private Limited
04.2015 - 11.2017
- Handled Root Cause Analysis (RCA) process on trends, identifying the underlying causes of errors or issues, and implementing Corrective and Preventive Actions (CAPAs) to prevent their recurrence
- Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs
Pharmacovigilance Scientist
Quantum Solutions India
06.2013 - 03.2015
- Expertise in management of Individual Case Safety Reports (ICSRs) of all case types which includes: Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities
- Registration of ICSRs into safety databases Conducting duplicate searches before registration and identifying potential duplicates
- Managing duplicate cases appropriately
- Data Entry of ICSRs in the safety database, including determination of the expectedness of the adverse events against various labelled documents (such as SmPC, CCDS, IBs etc.)
- Writing case summaries, accessing causalities
- Data Validation
- Expertise in MedDRA coding under 'MedDRA Term Selection: Points to consider'
Education
Master of Pharmacy -
Hari Singh Gaur Central University
Sagar, India07-2011
96.7 Percentile
GATE Qualified
01-2009
Bachelor of Pharmacy -
RNS Institute of Pharmaceutical Sciences
Gwalior, India07-2008
Skills
Analytical problem solver
Database Expertise
- LSMV
- LSR
- ARGUS
- AWARE
- TRACKWISE
- ARISG
- VEEVA VAULT
- EXPECTEDNESS TOOL
Timeline
Senior Drug Safety Specialist
PAREXEL International Services India Private Limited
04.2024 - Current
Drug Safety Specialist
PAREXEL International Services (India) Private Limited
07.2020 - 03.2024
Pharmacovigilance Specialist
Parexel International Services India Private Limited
11.2017 - 06.2020
Pharmacovigilance Analyst
Parexel International Services India Private Limited
04.2015 - 11.2017
Pharmacovigilance Scientist
Quantum Solutions India
06.2013 - 03.2015
Master of Pharmacy -
Hari Singh Gaur Central University
96.7 Percentile
GATE Qualified
Bachelor of Pharmacy -
RNS Institute of Pharmaceutical Sciences
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