Job for Drug Safety Associate at Bioclinica
Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post Approval Research division.
Post : Drug Safety Associate
Essential Duties and Responsibilities
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.
• Following up with sites regarding outstanding queries.
• Follow up on reconciliation of discrepancies.
• Follow departmental AE workflow procedures
• Closure and deletion of cases
• Perform any other drug safety related activities as assigned
• Perform literature review activities when trained and assigned.
Location : Mysore, India
Industry Type : Pharma
Functional Area : Drug Safety
End Date : 10th July, 2018
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