Company Name:-
Covance

Job Location:-
Bengaluru, Karnataka

Job Summary:-
Job Overview:
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:
entry of safety data onto adverse event database(s) and tracking systems
review of adverse events for completeness, accuracy and appropriateness for expedited reporting
write patient narratives
code adverse events accurately using MedDRA
determine expectedness/listedness against appropriate label
identifies clinically significant information missing from initial reports and ensures its collection
ensure case receives appropriate medical review
prepare follow-up correspondence consulting the medical staff accordingly.

ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines
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.

Possess knowledge of other procedural documents, e.

g.

, SOPs, etc.

that impact Safety.

Ensure compliant safety reporting in accordance with US and

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