Contingent Worker Jobs in Bangalore - COVANCE
Job Description
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
Job Particulars
Role others
Who can apply Freshers and Experienced (0 to 0.6 Years )
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id654399
Job Category BSc/BCA/BBM
Locality Address
State Karnataka
Country India
About Company
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.
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