Vidya Shivaji Gaikwad
Pune
Summary
Results-driven Senior process executive with over 6.9 years of experience in pharmacovigilance. Expertise in MedDRA coding, narrative writing, and quality review enhances compliance and safety reporting. Proficient in Argus and safety tracking systems, committed to maintaining regulatory compliance and data integrity.
Overview
7
7
years of professional experience
Work History
Senior process executive
Cognizant Technology solutions
Pune
08.2024 - Current
- Processed and tracked Pharmacovigilance data for clinical trials, spontaneous, and post-marketing studies while ensuring adherence to safety reporting protocols.
- Conducted data entry and quality review in Pharmacovigilance databases to ensure timely submission of reports and adherence to regulatory standards.
- Mentored team members on tracking action items and case assignments to improve workflow and accountability.
- Drafted safety narratives to summarize key findings and ensure compliance with regulatory requirements.
- Drafted concise individual case summary reports and narrative summaries in accordance with company/product conventions.
- Coded adverse reactions using MedDRA and maintained accuracy in safety data entry for assigned projects.
- Generated and managed follow-up queries to enhance completeness and regulatory compliance of ICSR information.
- Assessed case severity to prioritize timely follow-up and mitigate safety risks.
- Identified and managed duplicate or invalid ICSRs in accordance with Standard Operating Procedures (SOPs).
- Provided mentoring on Argus case processing and triage techniques to enhance team performance.
Safety science coordinator
Fortrea India Pvt. Ltd.
Pune
04.2021 - 07.2024
- Managed case processing and narrative writing for safety reports in clinical trials and spontaneous reporting, ensuring compliance with global regulatory requirements.
- Prioritized and performed quality review of ICSRs, verifying the accuracy and completeness of safety information.
- Coordinated follow-up queries and monitored responses, ensuring data integrity in safety tracking systems.
- Identified and resolved duplicate or invalid ICSRs, maintaining adherence to established SOPs.
- Utilized MedDRA for accurate coding of adverse reactions and maintained the drug dictionary through systematic event coding.
- Executed data entry into tracking and Pharmacovigilance databases, delivering reports in compliance with regulatory guidelines.
- Mentored new hires in best practices for case assignment and action item tracking, fostering professional collaboration.
Trainee junior data analyst
Cognizant Technology solutions
Pune
10.2019 - 04.2021
- Assisted in case processing and narrative report writing for ICSRs within spontaneous, patient-oriented, noninterventional, and post-marketing studies.
- Applied MedDRA coding techniques for adverse reactions, contributing to consistent safety data management.
- Facilitated follow-up queries and monitored case severity, ensuring timely resolution and compliance with safety protocols.
- Executed data entry and tracked Pharmacovigilance information, maintaining adherence to quality review standards.
- Assisted in clinical assessments, including seriousness evaluation, labeling, and causality determination, ensuring alignment with SOPs.
Education
B.Pharmacy -
Shri Bhagwan college of pharmacy
Aurangabad01-2017
Skills
- Case Processing
- Narrative Reporting of ICSRs
- Clinical Trial Experience
- Safety Reporting
- MedDRA Coding
- Quality Review
- Follow-Up Query Generation
- Case Severity Assessment
- Mentoring
- Training
- Action Items Tracking
- Case Assignment
- Regulatory Compliance
- Operational Knowledge of ARGUS
Timeline
Senior process executive
Cognizant Technology solutions
08.2024 - Current
Safety science coordinator
Fortrea India Pvt. Ltd.
04.2021 - 07.2024
Trainee junior data analyst
Cognizant Technology solutions
10.2019 - 04.2021
B.Pharmacy -
Shri Bhagwan college of pharmacy