safety science coordinator jobs – Labcorp – Bangalore
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.
