PARYUL JAIN
Clinical Operations Specialist
Bangalore,KA
Summary
Results-oriented pharmacovigilance professional with over 3.5 years of experience in clinical safety operations encompassing drugs, medical devices, vaccines, in vitro devices (IVDs), and software-based devices (SaMD/SiMD). Specialized in end-to-end management of clinical trials, and proficient in signal detection, post-market surveillance, and regulatory submission (EMA, BfArM, Health Canada, FDA, PMDA). Adept at establishing SOPs, developing operations plans, and training frameworks. Recognized for excellence in audit readiness and stakeholder collaboration.
Overview
5
5
years of professional experience
5
5
years of post-secondary education
Work History
Safety Operations Specialist
IQVIA RDS Pvt. Ltd.
Bangalore, KARNATKA
06.2022 - Current
• Managed the safety operations for an oncology study initiation, contributing to the study protocol, safety management plan, complaint plan, and CRF development, leading to timely FPI.
• Streamlined operational workflows by coordinating cross-functional teams for enhanced efficiency.
• Configured ARGUS database in collaboration with IT teams for advanced drug-device hybrid studies.
• Ensured proper data archival during close-out activities for multiple studies, contributing to clean audit findings during client inspections.
• Trained new team members as a subject matter expert, fostering knowledge retention and capability enhancement.
• Engaged in UAT meetings and client communication calls to facilitate project-related activities on schedule.
• Carried out regulatory reporting submissions across various global authorities, maintaining 100% compliance with the applicable guidelines (ICH-GCP, ISO 14155, MDR, and FDA 21 CFR).
• Executed end-to-end case processing involving TRIAGE report review, source document review, case entry, AE coding (MeDRA, IMDRF), dossier preparation, narrative writing, and adjudication across therapeutic areas.
Industrial Trainee
Super Formulation Pvt. Ltd.
Ujjain
01.2021 - 02.2021
• Documented production processes and maintained accurate records.
• Participated in safety training and adhered to safety protocols.
• Conducted quality checks on raw materials and final products.
Education
Diploma - Clinical Research and Pharmacovigilance
Omasy Research
Chennai 05.2021 - 05.2022
B.Tech - Biotechonology
SRM Institute of Science And Technology
Chennai 05.2018 - 05.2022
Higher Secondary Education - CBSE Board
SYNA International School
Katni12.2017
Skills
- Project management
- Safety operations planning and development
- Study start-up, study close-out, and user acceptance testing
- Clinical trial database system handling (Medidata RAVE)
- Safety database configuration (ARGUS, ArisG, Veeva Vault)
- Clinical data analysis with signal detection
- End-to-end case processing
- Adverse event coding (MeDRA, WHO DD, IMDRF)
- Regulatory reporting (E2aB, MDCG, DSURs, PSURs, CIOMS, R3)
- Audit handling
- Quality control and assurance
- Client relations
- Risk management
- Training and development
- Software: Microsoft Excel, Power BI, Tableau
Languages
- Hindi, Native speaker
- English, Level C1
- French, Level A1
- Japanese, Level N5
Awards & Honors
- IMPACT Awardee, Q3 2025: Seamless management of the start-up for a new study, with stringent timelines and UPT review for a new study.
- SPOTLIGHT Awardee, Q1 2025: Demonstrated a proactive approach, speed, willingness to take on challenges, and dedication during the clinical trial study DMC snapshot.
- Winner of the IQVIA Pharmacovigilance Week 2024 on Building ADR Reporting Culture for Patient Safety.
- SPOTLIGHT Awardee, Q2 2023: Achieved sign-off on all activities for a high-volume study in a short span; performed manual DRU, and daily tracking of all study activities.
- SPOTLIGHT Awardee, Q4 2024: Stood out as a rapid learner, and engaged the team in extracurricular activities by conducting fun activities and team outings.
- Presenting author at the International Conference on Recent Advances in Biosciences and Bioengineering (ICRABB), 2022.
Timeline
Safety Operations Specialist
IQVIA RDS Pvt. Ltd.
06.2022 - Current
Diploma - Clinical Research and Pharmacovigilance
Omasy Research
05.2021 - 05.2022
Industrial Trainee
Super Formulation Pvt. Ltd.
01.2021 - 02.2021
B.Tech - Biotechonology
SRM Institute of Science And Technology
05.2018 - 05.2022
Higher Secondary Education - CBSE Board
SYNA International School