Contingent Worker jobs in Bangalore at COVANCE

Contingent Worker

Location : Bangalore, India

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
provide independent QC of AE reports for other members of the group
May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
Maintain a strong understanding of Covance’s safety database conventions or client-specific database conventions, as appropriate.
Participate in signal detection, trend and pattern recognition activities, as appropriate.
Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs),Annual IND reports, European Annual Safety Reports (ASRs),Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports.
Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
Work with Data Management or client on reconciliation of safety databases, if appropriate.
Monitor workflow for assigned studies/programs to ensure all deadlines are met

Education/Qualifications: Life science Graduate - preferable BPharm/MPharm/PharmD

Experience: 0-6 months or Fresher

Covance Inc., the drug development business of LabCorp®, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real.Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions.