Summary
Overview
Work History
Education
Skills
Certification
References
Hobbies and Interests
Accomplishments
Languages
Timeline
Generic

Kajol Verma

New Delhi

Summary

Pharmacovigilance professional with six years of international experience in drug safety operations, including case processing, signal detection, and regulatory compliance. Committed to improving patient safety through effective risk management and adherence to global pharmacovigilance regulations. Skilled in optimizing workflows and ensuring high standards of quality and compliance in all aspects of drug safety.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Operations Specialist

IQVIA
Noida
11.2023 - Current
  • Working in a special project with J&J in my role as an IPV Affairs CAPA Specialist
  • Manage records and reporting for inspections, CAPAs, and nonconformance across APAC and EMEA regions.
  • Prepare presentations and lead regular team meetings to ensure smooth project execution.
  • Coordinate with stakeholders and assist in audits, kick-off meetings, and investigator meetings.
  • Maintain regulatory compliance and perform risk assessments in alignment with industry and sponsor standards.

IPV Case Management Specialist

JOHNSON & JOHNSON
Gurgaon
03.2021 - 11.2023
  • Managed international and domestic case intake, triage, and data entry in ARIS-G (Lifesphere) and i-Medical Orion databases.
  • Handled clinical trial cases and prepared submissions to CDSCO via the SUGAM portal for India-specific regulatory compliance.
  • Processed solicited and unsolicited safety cases, including adverse events, adverse drug reactions, and product quality complaints.
  • Conducted evaluation and assessment of serious ADRs to ensure timely escalation and compliance.
  • Prepared and submitted SUSARs to global and local health authorities.
  • Acted as a Subject Matter Expert (SME) for Consumer Pharmacovigilance, ensuring best practices and training delivery.
  • Conducted monthly Impact Assessments and ensured SOP adherence across pharmacovigilance processes.
  • Managed expedited reporting and regulatory submissions to multiple health authorities, including DCI, PVPI (India), ACCC (Australia), and TGA.
  • Ensured compliance tracking and metrics management using G-Metrics and Compass systems.
  • Performed medical literature reviews using OVID and other scientific databases for signal detection and case processing.
  • Coordinated follow-ups with healthcare professionals (HCPs) to ensure complete and accurate case information.
  • Conducted periodic reconciliations with vendors and clients to maintain data accuracy and compliance.

Pharmacovigilance Analyst

ELI LILLY AND COMPANY
Gurgaon
08.2019 - 03.2021
  • Handled complete processing of ICSRs in Argus Safety, including data entry, coding, narrative writing, and medical review, in compliance with regulatory standards.
  • Managed safety submissions for domestic clinical trials in accordance with local regulatory requirements.
  • Prepared and submitted PSURs and PSMFs to support regulatory compliance and safety reporting.
  • Maintained trackers for ICSRs, and regulatory submissions to ensure timely follow-up, and audit readiness.
  • Responded to queries, processed follow-up cases, and managed action items from stakeholders.
  • Performed monthly case reconciliations with vendors, and quality checks of PSP call recordings with customers for hidden AE and PQC cases.

Education

IELTS Exam -

IELTS Score
07-2022

Master Of Pharmacy -

Jamia Hamdard University
05-2019

Bachelor Of Pharmacy -

Ram-eesh Institute
05-2017

Intermediate -

Kendriya Vidyalaya Gr. Noida
03-2013

Matriculation -

Kendriya Vidyalaya Gr. Noida
03-2011

Skills

  • Regulatory compliance
  • Quality investigation
  • Risk assessment
  • NCs, audits, CAPA, and inspection
  • AEs, ADRs, and PQC evaluation
  • HA and SUSAR Submissions
  • PSURs and PSMFs
  • Literature review
  • Clinical trial cases
  • Team leadership
  • Good communication
  • Multitasking
  • Taking initiatives
  • Problem solving
  • Good organizational skills
  • Time management
  • Creative thinking
  • Microsoft Office

Certification

  • Participated in the IPR workshop
  • Participated in a workshop on human values and ethics
  • Attended a series of seminars at Jamia Hamdard, New Delhi
  • Attended the 86th World Congress on Nanomedical Sciences, 'NISSCON 2018,' at Vigyan Bhawan
  • Attended a conference on 'Recent Advances in Pharmaceutical Sciences and Health' at SPER Jamia Hamdard, New Delhi
  • Attended the National Conference on 'Current Approaches and Advancements'
  • Attended the 3rd national seminar 'PHARMASPEAK' on generic vs. branded drugs – a 360-degree overview on cost, benefits, and efficacy at Lloyd Institute, Greater Noida
  • Attended the International Conference 'Challenges for Global Competitiveness of Ayush and Natural Products and IASTAM Oration and Award Function' at DIPSAR, New Delhi

References

  • Aparna Sharma, +91 858-782-8481, Johnson & Johnson Pvt Ltd., AP-SEA Case Management Team Lead
  • Hina Talwar, +91 9811759588, Paraxel International India Pvt Ltd., Safety Services Project Leader

Hobbies and Interests

Hobbies: travel, reading, writing journals, dancing, photography

Accomplishments

  • Rewarded for maintaining 100% compliance in the year 2023 at Johnson & Johnson Pvt. Ltd
  • Became a subject matter expert in 2022 in consumer pharmacovigilance for Australia, New Zealand, the Philippines, Malaysia, and Singapore
  • Contributed to Audit 2023 as a subject matter expert within IPV for all matters related to QI and CAPAs, and provided advice or support on questions or concerns related to it

Languages

English
Proficient (C2)
C2
Hindi
Native
Native

Timeline

Operations Specialist

IQVIA
11.2023 - Current

IPV Case Management Specialist

JOHNSON & JOHNSON
03.2021 - 11.2023

Pharmacovigilance Analyst

ELI LILLY AND COMPANY
08.2019 - 03.2021

IELTS Exam -

IELTS Score

Master Of Pharmacy -

Jamia Hamdard University

Bachelor Of Pharmacy -

Ram-eesh Institute

Intermediate -

Kendriya Vidyalaya Gr. Noida

Matriculation -

Kendriya Vidyalaya Gr. Noida

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