Gunjan Sirola
Burari
Summary
Senior pharmacovigilance professional with 4.5 years of experience in end-to-end ICSR management. Proficient in global safety platforms. Skilled in authoring clinical narratives, managing workflows, and executing thorough data quality checks. Consistently meets global health authority deadlines, and adheres to regulatory requirements.
Overview
7
7
years of professional experience
Work History
Senior Pharmacovigilance Executive
Elite Safety Sciences
Gurugram
06.2023 - Current
- Conducted thorough checks for duplicates to ensure accurate data entry in Argus database.
- Executed initial seriousness assessments, and managed duplicate searches for ICSR actions.
- Prioritized daily case workflow to boost efficiency in processing tasks.
- Maintained compliance with established policies and procedural guidelines.
- Crafted narratives per client specifications to fulfill project requirements.
- Verified accuracy of all case information during Book-in/Triage and Data entry/QC processes.
- Facilitated timely follow-up communication with physicians, addressing action items diligently.
- Mentored new safety associates on Argus navigation and processing methods.
Drug Safety Specialist
PharmaLex Ltd
Noida
04.2021 - 06.2023
- Assessed cases appropriately for company/non-company categorization and managed distribution effectively.
- Streamlined workflow management of cases based on priority assignments across the team.
- Executed precise data entry, quality checks, and triaging of ICSR data within global safety databases (Veeva vault/Sapphire/AB cube).
- Applied MedDRA coding for events while conducting thorough causality assessments and narrative writing.
- Assisted in preparing documents for internal project reviews in alignment with project specifications.
- Conducted peer reviews to uphold quality standards and ensure consistent case processing.
- Evaluated expedited reporting requirements to Health Authorities, ensuring compliance with reporting timelines.
- Compiled standard reporting formats including CIOMS and XML files as requested.
Summer Intern
Mankind Pharma Ltd
Okhla
06.2019 - 07.2019
- Worked as a product management intern during summer internship.
Education
Bachelor of Pharmacy - Pharmacy
JAMIA HAMDARD UNIVERSITY
Delhi01.2020
Skills
- Case processing and mailbox management
- Workflow and time management
- Team collaboration and interpersonal skills
- Attention to detail and adaptability
- Communication skills
- Microsoft Office proficiency
- Safety database expertise
Languages
- English
- Hindi
Timeline
Senior Pharmacovigilance Executive
Elite Safety Sciences
06.2023 - Current
Drug Safety Specialist
PharmaLex Ltd
04.2021 - 06.2023
Summer Intern
Mankind Pharma Ltd
06.2019 - 07.2019
Bachelor of Pharmacy - Pharmacy
JAMIA HAMDARD UNIVERSITY