Shreya Singh
Pharmacovigilance associate
- Role
- Pharmacovigilance Associate at Kinapse
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Shreya Singh
Ph.D-qualified pharmaceutical professional with 11+ years of experience across…
Experience
Pharmacovigilance Associate
Feb 2017 — Present
Literature Searches and validation for efficacy of adverse event. Convergent with Global Safety Data Base ‘ARGUS\' Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Perform registration of initial and follow up information for cases in safety database. This includes duplicate check, entry of minimal information into the safety database according to the prescribed work instruction. Ensure all medically relevant information is transcribed from source documents into the appropriate fields of the safety database. This includes accurate and consistent data entry of relevant information, narrative writing, review and/or correction of data found to be in error. Review, rank, verify, process and document: event terms; special scenarios; product complaint information. Based on assessment of cases, process accordingly. Determine and perform appropriate case follow-ups Convergent in doing cross-linking as well as cross referencing of the case reports. Convergent in labelling of the events as per the labelling documents. Convergent with MedDRA coding of Relevant Medical History, Indication, events and lab details. Convergent in assessing reporter’s causality. Convergent in labelling of the events as per the label documents. Convergent with MedDRA coding of Relevant Medical History, Indication, events and lab details.
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