Stuti Gogoi
Bangalore
Summary
Drug Safety and Pharmacovigilance Professional with 7+ years of global experience in clinical and post-marketing safety. Skilled in authoring and reviewing aggregate safety reports (e.g., DSURs, ASRs), performing literature searches and ensuring end-to-end regulatory compliance. Proven ability to collaborate effectively across regulatory, clinical, and safety teams in GxP-compliant environments. Adept at ensuring audit readiness, SOP adherence, and mentoring junior staff to maintain quality and consistency in safety operations.
Overview
8
8
years of professional experience
Work History
Senior Safety Science Specialist
Fortrea
Bangalore
02.2023 - Current
- Lead pharmacovigilance operations for global clinical trials, ensuring timely and accurate reporting of AEs/SAEs and compliance with regulatory timelines.
- Contribute to the preparation of aggregate reports including DSURs and ASRs in collaboration with medical writers and regulatory teams.
- Perform literature searches and assist in line listing generation for regulatory submissions.
- Support Veeva Vault RIM documentation and ensure timely completion of assigned regulatory tasks.
- Ensure audit, SOP, and training compliance across safety processes and documentation.
- Collaborate with cross-functional R&D and regulatory teams to deliver safety-related documentation in alignment with global standards.
- Mentor junior safety associates and conduct peer quality reviews to ensure accuracy and consistency of safety deliverables.
Drug Safety Associate
Novotech
Bangalore
06.2021 - 02.2023
- Drafted Safety Management Plans and contributed to the setup and maintenance of safety databases.
- Authored narratives, processed ICSRs, and participated in the creation of periodic aggregate safety reports (DSURs, ASRs).
- Conducted line listing reconciliation and contributed to regulatory submissions under GVP-compliant frameworks.
- Actively participated in regulatory audit readiness through SOP compliance, training tracking, and CAPA implementation.
- Coordinated with external collaborators and internal stakeholders for ongoing safety and regulatory deliverables.
Operation Specialist
QuintilesIMS (IQVIA)
Bengaluru
06.2017 - 06.2021
- Performed end-to-end case processing and narrative writing for global pharmacovigilance cases.
- Participated in system validation (UAT, SIT) and database testing for Argus/ArisG systems.
- Supported client-specific audits and project initiatives, contributing to training and quality process improvements.
- Triaged incoming safety data and prioritized workflows based on seriousness and regulatory timelines.
Education
Master of Pharmacy -
Dibrugarh University
Assam09-2016
Skills
- Regulatory Tools: Veeva Vault RIM, Argus Safety, ArisG
- Document Types: DSURs, ASRs, Line Listings, Safety Management Plans
- Compliance: GxP (GCP, GLP), Audit Readiness, SOP Adherence
- Data Analysis: Literature Search, Line Listing Generation, Sales Data Extraction
- Software: iMedidata Rave, Power BI, MS Office Suite
- Other: Cross-functional Collaboration, Medical Writing Support, Training Compliance
Websites
Timeline
Senior Safety Science Specialist
Fortrea
02.2023 - Current
Drug Safety Associate
Novotech
06.2021 - 02.2023
Operation Specialist
QuintilesIMS (IQVIA)
06.2017 - 06.2021
Master of Pharmacy -
Dibrugarh University
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