Rohan Tyagi
Delhi
Summary
Results-driven pharmacovigilance specialist with a solid history at Syneos Health, focusing on adverse event monitoring and ICSR processing. Expertise in regulatory compliance and comprehensive case documentation. Committed to optimizing safety reporting and enhancing compliance measures. I foster team collaboration and drive quality improvements, ensuring timely and accurate reporting. Passionate about enhancing safety standards in drug development.
Overview
5
5
years of professional experience
2
2
Certifications
Work History
Safety and PV Specialist I - Pharmacovigilance
Syneos Health
Gurugram
01.2023 - 11.2025
- Triaged ICSRs, evaluating data for completeness, accuracy, and regulatory reportability.
- Processed ICSRs in compliance with Standard Operating Procedures and safety plans to ensure regulatory adherence.
- Generated timely, accurate expedited reports in compliance with regulatory standards.
- Entered information into PVG quality and tracking systems to streamline ICSR receipt and tracking.
- Entered data into safety database for efficient access and analysis.
- Documented patient events in detail to ensure accurate medical records., medical histories, concomitant medications, and tests accurately.
- Compiled narrative summaries to fulfill reporting requirements and support regulatory compliance.
- Identified queries, ensuring follow-up until satisfactory resolution of all information gaps.
- Created training materials for new hires on the company's procedures and policies.
- Coordinated project timelines with cross-functional teams to ensure alignment.
Drug Safety Associate - Pharmacovigilance
Qinecsa solutions (Formerly known as Bioclinica India Pvt. Ltd.)
Mysore
12.2021 - 01.2023
- Monitored adverse event reports to ensure regulatory compliance and safeguard patient safety.
- Reviewed data accuracy and completeness within safety database.
- Executed comprehensive data entry for individual case safety reports in safety database.
- Tracked quality metrics to enhance compliance and support ongoing process improvement initiatives.
- Participated in internal audits to uphold quality standards.
- Conducted training sessions for junior staff on safety protocols and procedures.
- Provided constructive feedback to enhance team knowledge and adherence to safety protocols.
Drug Safety Specialist - Pharmacovigilance
PharmaLex Pvt. Ltd.
Noida
10.2020 - 12.2021
- Qualified Classifications Rater Test to detect suspicious adverse drug reactions.
- Collaborated with Medical Advisors to create ICSRs accurately.
- Processed literature cases to maintain accurate records, supporting pharmacovigilance efforts.
- Screened scientific literature using internal search mechanism to identify relevant studies.
- Updated processed ICSRs with EMA services, enhancing compliance and regulatory alignment.
- Communicated case information to clients to ensure awareness and understanding. regarding case information through MLM channels.
- Documented individual case processing activities, ensuring traceability and compliance.
- Organized and participated in internal project organization meetings for enhanced teamwork.
Education
Bachelor of Pharmacy - Pharmacy
Amity University
Noida, Uttar Pradesh06-2020
Senior Secondary -
Apex Public School
Delhi06-2015
Higher Secondary -
Mount Olivet School
Delhi03-2013
Skills
- Literature screening and review (PubMed, Embase, Medline)
- Aggregate report preparation (PBRER, PSUR, DSUR, PADER)
- Signal detection and RSI assessment
- Pharmacovigilance compliance and regulations
- Client communication and project management
- Adverse event reporting
- ICSR processing
- Adverse event monitoring
Technical Skills
- Literature search tools: PubMed, Embase, and Medline
- Regulatory databases: Oracle Argus, ArisG, Veeva Vault, and Safety Easy
- Data analysis tools: Excel
- Medical terminology: MedDRA, WHO-DD, and MeSH
Disclaimer
I do hereby declare that all the information given above is true to the best of my knowledge and belief
Languages
English
Advanced (C1)
C1
Hindi
Native
Native
Certification
Internship at Bio-Med Healthcare Pvt. Ltd.
Timeline
Safety and PV Specialist I - Pharmacovigilance
Syneos Health
01.2023 - 11.2025
Drug Safety Associate - Pharmacovigilance
Qinecsa solutions (Formerly known as Bioclinica India Pvt. Ltd.)
12.2021 - 01.2023
Drug Safety Specialist - Pharmacovigilance
PharmaLex Pvt. Ltd.
10.2020 - 12.2021
Bachelor of Pharmacy - Pharmacy
Amity University
Senior Secondary -
Apex Public School
Higher Secondary -
Mount Olivet School