Yogesh Chopde
Pune,India
Summary
Senior Safety Science Specialist at Fortrea with over 6 years of experience in pharmacovigilance. Expert in case intake monitoring, case processing, and providing training to subordinates. Currently responsible for managing workflows and ensuring the quality of case intake and case processing. Competent in leveraging GVP and ICH guidelines and comply with EU and US FDA for regulatory submissions. Dedicated to maintaining high standards in pharmacovigilance operations and contributing to the safety of medical products globally.
Accomplished professional with expertise in MedDRA coding, aggregate reports (PSUR/DSUR), and safety database management. Demonstrates strong capabilities in drug safety monitoring, ICSR case handling, and adverse drug reactions. Known for problem-solving skills, adaptability, and attention to detail, ensuring effective case processing and intake. Proficient in signal detection and management with a commitment to maintaining high standards of time management and work ethic.
Overview
6
6
years of professional experience
Work history
Senior Safety Science Specialist
Fortrea
Pune, India
2019.11 - Current
- Managed the end-to-end processing of complex adverse event information in safety databases (e.g., Argus, ArisG) from diverse sources including clinical studies, spontaneous reports, and literature, consistently meeting stringent regulatory timelines.
- Drafted and reviewed accurate, concise, and chronological case narratives for Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs), ensuring regulatory compliance and data integrity for clinical study reports.
- Performed precise medical coding for adverse events, medical history, and concomitant medications using MedDRA and WHO-Drug dictionaries, ensuring high-quality data standardization for regulatory submission.
- Conducted comprehensive medical review of Individual Case Safety Reports (ICSRs), accurately assessing seriousness, expectedness, and causality to ensure regulatory compliance and patient safety.
- Managed the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory authorities (FDA, EMA, etc.), ethics committees, and investigators, maintaining 100% compliance with mandatory safety reporting timelines.
- Ensuring that serious, unexpected adverse reactions (SUSARs) and other reports are submitted to regulatory authorities (FDA, EMA, etc.), ethics committees, and investigators within strict mandatory timelines.
- New resReviewing Individual Case Safety Reports (ICSRs) to determine seriousness, expectedness, and causality (the relationship between the drug and the event).ponsibility
- Contacting healthcare professionals, patients, or study sites to obtain missing or additional information needed for assessment.ponsibility
- Validating data consistency, ensuring accuracy of case processing, and performing QC on case narratives.nsibility
- Working in adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GVP).
- Managed team allocations, training, and performance tracking. Mentor team members to meet KPIs, deliver high-quality work, and provide comprehensive training on case processing workflows to ensure smooth onboarding and professional growth.
- 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.
- Database Expertise: Utilize the ARGUS safety database for adverse event comparison, follow-up reporting, and maintaining the quality and accuracy of Individual Case Safety Reports (ICSRs). Also worked in LifeSphere Safety 2022.2.
Education
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy, JSS University
Mysuru/India /2014 - /2016
Bachelor of Pharmacy - Pharmacy
Poona Collehe of Pharmacy, Bharati Vidyapeeth University
Pune/India /2010 - /2014
Skills
- MedDRA Coding
- Aggregate Reports (PSUR/DSUR)
- MedDRA Coding
- Safety Database Management
- Drug Safety Monitoring
- ICSR Case Handling
- Problem solving
- Adaptability/ Work Ethic
- Attention to detail
- Time management
- Adverse Drug Reactions
- Case Processing
- Case Intake
- Signal Detection and Management
Language
Hindi, Marathi and English
Languages
Hindi
Beginner
English
Beginner
Marathi
Beginner
Timeline
Senior Safety Science Specialist
Fortrea
2019.11 - Current
Master of Pharmacy - Pharmaceutics
JSS College of Pharmacy, JSS University
/2014 - /2016
Bachelor of Pharmacy - Pharmacy
Poona Collehe of Pharmacy, Bharati Vidyapeeth University
/2010 - /2014