Monika Girase

• Highly skilled Pharmacovigilance and Safety Data professional with 6+ years of experience in ICSR processing, case initiation, safety narrative writing, and regulatory compliance.

• Expertise in Vault Safety, ARISg, ECR AgXchange, and case management workflows.

• Demonstrated ability in training, automation handling, quality oversight, and team collaboration. Strong analytical mindset with experience in handling clinical, spontaneous, and solicited cases across global markets.

• Trained the trainee on database and convection of the triage processes on Arisgs,Agxchange and VVS database

• Conducted causality assessment, labelling evaluations, and narrative writing using MedDRA coding.

• Managed case workflows, allocation / Tracking, Handled all Ad-hovc activity

• Participated in the ARISg to Veeva Vault Safety migration; performed system validation and smoke testing.

• Effectively managed all backup operations while leading the team to maintain business continuity and operational efficiency.

• Monitored case acknowledgements (ACKs), investigated technical and business rejections, and coordinated follow‑ups to ensure successful case acceptance.