safety science coordinator jobs – Labcorp – Bangalore

safety science coordinator 1 job vacancies at bangalore0a2006343079047608599

Safety Science Coordinator – 1 Job vacancy at Bangalore

Job Description :

  • Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:
  • maintenance of adverse event tracking systems
  • set-up and maintenance of project files, core process files, and central safety files o reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.
  • Provide administrative support to PSS personnel (e.g. proofreading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).
  • Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Spec I PSS/Snr Spec PSS.
  • Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).
  • Where applicable, check the PSS hotline mailbox regularly for reported SAEs and forward messages to the designated Spec I PSS/Snr Spec PSS.
  • Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
  • Coordinate shipments of safety documents.
  • Prepare and coordinate safety study files for archiving at the completion of projects.
  • Arrange and schedule internal and external meetings/teleconferences.
  • Train and mentor the PSS Support Specialists in their day-to-day activities.
  • Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
  • Build and maintain good PSS relationships across functional units.
  • Any other duties as assigned by management
  • Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
  • Assist in producing queries of safety data for clients as appropriate.
  • Assist in the generation and maintenance of the PV&DSS metrics.
  • Assist Data Management or clients on the reconciliation of safety databases.
  • Provide input for monthly status reports.
  • Maintains a comprehensive understanding of 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, and how they impact safety.
  • Build and maintain good PV&DSS relationships across functional units.
  • Demonstrate role-specific Core Competencies on a consistent basis.
  • Demonstrate company Values on a consistent basis.
  • Assist in the preparation of client meetings and liaise with clients where appropriate.
  • Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
  • Any other duties as assigned by management.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability, or veteran status.

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safety science coordinator 1 job vacancies at bangalore0a2006343079047608599
safety science coordinator jobs

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