Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.
Post : Drug Safety Associate
Job Description
As Case Intake Member:
• Responsible for case intake, duplicate check , and registration
• Maintain log of source documents and other communications
As Case Processor:
• Responsible for data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures
• Process all incoming cases in order to meet timelines
• Full data entry including medical coding and safety narrative
As Medical Coder
• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
As Narrative Writer
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
As Literature Review Specialist
•Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
• Review of literature articles to identify case safety reports.
• Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
• Assist in signal generation and safety analysis activities.
• Ensure quality of literature searches and reporting.
• Review of local/global literature reports to determine regional reportability.
• Create/maintain study summary documents.
• Assist with narrative writing for periodic/ad hoc submissions.
• Assist with ad hoc or routine safety monitoring activities
Additional Information
Work Location : Mysore
Experience : 0 to 2 Years ( ANY)
Education : M PHARMACY, PHARM D, BDS, MDS, MSc / BSc (Nursing)
Walk In Interview
Date : Thursday & Friday , 25th & 26th Oct between 9 AM to 1 PM
Venue : Bioclinica India Pvt Ltd Silver Spirit Tech Park 317 (P), (PII) 318, Hebbal Industrial Area, Mysore-16
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