Bioclinica is a global life sciences solution provider of Pharmacovigilance, Regulatory Affairs, Cardiac Safety, Molecular Marker Laboratory, Trial Supply Optimization, eHealth Cloud, App Xchange, Clinical Adjudication ,Clinical Trials, Medical Imaging, Clinica Trial Management System (CTMS), Risk-Based Monitoring, Site Network, Electronic Data Capture ( EDC) and Payments & Forecasting.
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.
Candidate Profile
UG: B.Sc - Nursing, B.Pharma - Pharmacy, BAMS - Any Specialization, BHMS - Any Specialization
PG: MS/M.Sc(Science) - Any Specialization, Nursing, M.Pharma - Pharmacy, MDS - Any Specialization
Additional Information:
Experience: 0 - 2 yrs
Qualification: B PHARMACY, M PHARMACY, PHARM D, BDS, MDS, BAMS, BHMS, BSC NURSING, MSC NURSING
Location: Mysore
Industry Type: Pharma
Walk in Interview
Date : SUNDAY, 13th MAY between 9 AM to 1 PM at the below address
Venue : COMMUNE COWORKS
# 139, FIRST CROSS ROAD, V BLOCK,
A CROSS ROAD, KORAMANGALA,
BANGALORE, BANGALORE - 95
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