Job for Drug Safety Associates at Bioclinica | M.Pharm, M.Sc, B.Pharm
BIOCLINICA is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica delivers focused service supporting multifaceted technologies such as Medical Imaging, Cardiac safety services, Molecular marker laboratory, Drug Safety and Regulatory solutions, Network of research sites, patient recruitment-retention services, and a post-approval research division. Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations - including all of the top 20 - through a network of offices in the U.S., Europe and Asia
Post : Drug Safety Associates
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.
Experience : 0 to 2 years
Qualification : B.Pharmacy, M.Pharmacy, Pharm.D, Bds, Mds, Bams, Bhms, B.sc Nursing, M.sc Nursing
Location : Cochin
Industry Type : Pharma
Functional Area : Drug Safety
Date and Time
5th May , 9 AM onwards
ABAD PLAZA, INNER CIRCLE, 1st FlOOR, NEAR CENTRE SQUARE MALL, ERNAKULAM,COCHIN - 682035.
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