Krishnakhi Das
Drug safety associate/PV/Gold medalist/Pharmacology/GPAT Qualified
- Role
- Pharmacovigilance Services Associate at Accenture
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Krishnakhi Das
A results-driven professional with a Master\'s degree in Pharmacology. I\'m committed to…
Experience
Pharmacovigilance Services Associate
Apr 2024 — Present · Bengaluru, IN
Case Prioritization:Prioritize case processing activities based on UCB guidelines, regulatory timelines, SLAs, and KPIs.Handle applicable cases end-to-end or as per client requirements.Case Processing:Enter safety information, including medical history, lab data, and therapy details, into the global safety database.Perform medical and drug coding using MedDRA/WHODD and assess case seriousness.Case Evaluation:Review reporter/company causality, prepare narratives, and update the E2B sender’s comment field as per SOPs.Assess listedness/expectedness and causality for serious and non-serious cases.Validate data consistency and make corrections as needed.Follow-Up:Identify missing/additional information, send follow-up requests, and incorporate responses.Archive case-related communications and ensure resolution of pending action items.Workflow Management:Coordinate R3 translations with vendors for local submissions.Route cases to the next workflow step or lock them as per guidelines.Handle case downgrades, upgrades, corrections, suppression, and nullification as necessary.Escalation and Collaboration:Escalate complex issues to team leads or process leads when necessary.Collaborate to address deviations from case processing conventions.Additional Responsibilities:Perform data entry for initial and follow-up source information in the safety database.Participate in special projects supporting case processing activities.
Education
NETES Institute of Pharmaceutical Sciences-Nemcare Group Of Institutions Guwahati Assam
Bachelors of Pharmacy, Pharmacy
Acharya B M Reddy College of Pharmacy
Master of Pharmacy, Pharmacology
Acharya
Masters of Pharmacy, Pharmacology
Acharya & BM Reddy College of Pharmacy
Master of pharmacy, Pharmacology and Toxicology
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