Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
This includes, but is not limited to :
o entry of safety data onto adverse event database(s) and tracking systems
o review of adverse events for completeness, accuracy and appropriateness for
expedited reporting
o write patient narratives
o code adverse events accurately using MedDRA
o determine expectedness / listedness against appropriate label
o identifies clinically significant information missing from initial reports and ensures
its collection
o ensure case receives appropriate medical review
o prepare follow-up correspondence consulting the medical staff accordingly.
o ensure all cases that require expediting reporting to worldwide regulatory agencies
are processed swiftly and appropriately within required timelines
o reporting of endpoints to clients, regulatory authorities, ethics committees,
investigators and Covance project personnel, if required, within study specified
timelines
Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.
Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual
Case Summary Reports (ICSRs) of Serious Adverse Events
Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety
Update Reports (PSURs).
Work with Data Management or client on reconciliation of safety databases.
Begin participating in the generation of monthly status and other project-specific reports ensuring
the quality and accuracy of metrics and data provided.
Support / train less experienced safety staff in all aspects of case-handling, adverse event reporting.
Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures
SOPs), Work Instructions (WI), guidance documents and directives associated with safety
management, reporting and pharmacovigilance.
Maintain a strong understanding of Covance’s safety database conventions or client specific database
conventions, as appropriate.
Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual
Case Summary Reports (ICSRs) of Serious Adverse Events
Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety
Update Reports (PSURs).
Work with Data Management or client on reconciliation of safety databases.
Begin participating in the generation of monthly status and other project-specific reports ensuring
the quality and accuracy of metrics and data provided.
Support / train less experienced safety staff in all aspects of case-handling, adverse event reporting.
Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures
SOPs), Work Instructions (WI), guidance documents and directives associated with safety
management, reporting and pharmacovigilance.
LI-NC1 REMOTE
Education / Qualifications :
Degree preferred to be in one or more of the following disciplines : Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
Experience :
Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
beneficial.
