Vaishnavi Ghansham Girme
Pharmacovigilance Associate
Pune
Summary
Highly skilled Pharmacovigilance Professional with 6 years of experience in ICSR processing, clinical trial safety, and regulatory compliance. Proficient in Argus Safety, MedDRA coding, literature screening, and global PV regulations (FDA, EMA, ICH-GCP, GVP). Strong in case management, quality control, project management, and cross-functional collaboration. Holds a B.Pharm and Executive MBA in Healthcare Management.
Overview
6
6
years of professional experience
Work History
Pharmacovigilance Associate
ICON Clinical Research
05.2023 - 11.2025
- Coordinated the intake of clinical trial cases, ensuring timely and accurate receipt of case information from sponsors and investigators.
- Sent notifications to relevant stakeholders, including clients, investigators, and internal teams, regarding case status updates, and processed triage to ensure prioritization of critical cases.
- Processed clinical trial cases with high accuracy and attention to detail, ensuring compliance with regulatory requirements and study protocols.
- Researched and resolved queries from clients and investigators in a timely and professional manner, escalating complex issues to senior management as necessary.
- Conducted thorough quality checks of ICSRs for clinical trial cases, ensuring accuracy and completeness of data before submission to regulatory authorities.
- Actively participated in client calls to address concerns and provide updates on case status.
- Handled project activities as lead, ensuring high-quality delivery, allocation of the cases, audit, and managing timelines and resources.
- Provided trainings and mentorship to the new members of the team.
- Therapeutic Area of Work: CT / Oncology – Cancer, Solid Tumour, Acute Myeloid Leukaemia (AML) / Phase 1 and Phase 3 cycles.
Pharmacovigilance Associate Level 3
APCER Life Sciences
11.2021 - 03.2023
- Conducted thorough triage of safety cases to ensure accurate classification and prioritization, ensuring prompt and effective response to critical incidents.
- Executed comprehensive case processing activities included case Intake, case triage review and adjunction of SAE(s)/ AE(s).
- Utilized online QC tools for self-check procedures, enhancing case accuracy and ensuring compliance with regulatory requirements.
- Processed specific types of cases, including SUSAR (Serious Untoward Adverse Reaction), Fatal, and Pregnancy cases.
- Promoted to QC position within 6 months and provided mentorship.
- Therapeutic Area of Work: CT / Oncology, post-marketing, and literature case.
Drug Safety Officer
Tata Consultancy Services
10.2019 - 11.2021
- Spearheaded case intake operations, ensuring meticulous duplicate checks and systematic registration.
- Executed precise data entry of individual case safety reports (ICSRs) into the safety database, upholding data integrity.
- Mastered the identification, interpretation, and extraction of adverse events from diverse source documents, enhancing case processing accuracy.
- Processing drug/device cases for various reports types including (Spontaneous/NIS/MAP/POP/PMS).
- Conducted thorough initial case reviews, evaluating AE information to determine necessary actions aligned with company protocols.
- Performed literature screening to identify potential signals and processed literature cases.
- Therapeutic Area of Work: CT / Oncology, post-marketing, device and literature case.
Education
MBA - Healthcare Management
University of Mumbai
01.2025
Bachelors of Pharmacy - undefined
University of Pune
06.2019
Skills
Case Processing
Drug Safety
Clinical Trial Safety
RCA
CAPA
Quality control reviews
Cross-functional team
Mentorship
Project Management
Audit
Argus
Veeva Vault
Regulatory Compliance
Timeline
Pharmacovigilance Associate
ICON Clinical Research
05.2023 - 11.2025
Pharmacovigilance Associate Level 3
APCER Life Sciences
11.2021 - 03.2023
Drug Safety Officer
Tata Consultancy Services
10.2019 - 11.2021
Bachelors of Pharmacy - undefined
University of Pune
MBA - Healthcare Management
University of Mumbai