Kritika Saini
@kritikasaini
I process and quality-review safety cases across clinical trials, organ vigilance, and post-marketing pharmacovigilance.
IndiaWhat I'm looking for
At Elite Safety Sciences, I process and quality-review clinical trial, organ vigilance, and post-marketing safety cases, including ICSR documentation, triage verification, MedDRA coding, and case tracking.
I've progressed from Pharmacovigilance Assistant to Senior Pharmacovigilance Executive while mentoring new joiners, managing case-processing workflows, and working with Oracle Argus Safety, Medrio, EDC, and Clinevo Safety. Earlier, I contributed to formulation and development work at Tirupati Group and completed an M. Pharm in Pharmaceutics.
Experience
Work history, roles, and key accomplishments
Senior Pharmacovigilance Executive
Elite Safety Sciences
Apr 2026 - Present (4 months)
Currently working on clinical trial cases, organ vigilance cases, and post-marketing cases. Performs quality review for PM cases and data entry for organ vigilance and CT cases.
Pharmacovigilance Executive
Elite Safety Sciences
Oct 2025 - Apr 2026 (6 months)
Processed literature, clinical trials, discharge summaries, and other hospital records. Handled quality reviewer position and performed quality checks of ICSR for accuracy and completeness.
Pharmacovigilance Associate
Elite Safety Sciences
Apr 2024 - Dec 2025 (1 year 8 months)
Recorded all ICSR documentation and tracked in accordance with Sponsor/client specifications. Verified case information entered at Book-in/Triage, including MedDRA coding of adverse events and SAEs.
Pharmacovigilance Assistant
Elite Safety Sciences
Oct 2023 - Apr 2024 (6 months)
Assisted in pharmacovigilance activities including case processing and documentation. Supported senior team members in ensuring compliance with regulatory standards.
Development Scientist
Tirupati Group
May 2023 - Oct 2023 (5 months)
Worked in formulation and development, contributing to pharmaceutical research and development projects.
Research Associate (Formulation & Development)
Tirupati Group
Sep 2021 - May 2023 (1 year 8 months)
Conducted research in formulation and development, supporting the creation and optimization of pharmaceutical products.
Education
Degrees, certifications, and relevant coursework
Himachal Pradesh Technical University
Master of Pharmacy, Pharmaceutics
2021 - 2023
Grade: 8.51 CGPA
Master of Pharmacy in Pharmaceutics with a CGPA of 8.51.
Himachal Pradesh Technical University
Bachelor of Pharmacy, Pharmacy
2017 - 2021
Grade: 8.21 CGPA
Bachelor of Pharmacy with a CGPA of 8.21.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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