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Labcorp Submissions Specialist - PSS in Spain

Job Overview:

Labcorp are hiring a Submissions Specialist - PSS to join our team, candidates can be based anywhere in EMEA, flexible home or office based working.

Role Description:

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:

o entry of safety data onto adverse event database(s) and tracking systems

o review of adverse events for completeness, accuracy and appropriateness for

expedited reporting

o write patient narratives

o code adverse events accurately using MedDRA

o determine expectedness/listedness against appropriate label

o identifies clinically significant information missing from initial reports and ensures

its collection

o ensure case receives appropriate medical review

o prepare follow-up correspondence consulting the medical staff accordingly.

o ensure all cases that require expediting reporting to worldwide regulatory agencies

are processed swiftly and appropriately within required timelines

o 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.

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.

#LI-NC1 REMOTE

Education/Qualifications:

Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

Experience:

  • Candidates should ideally have a least 6 to 12 months Safety Submissions experience.

  • Have a high degree of accuracy with attention to detail.

  • Function as a team player.

  • Good communication skills and must be able to communicate effecitively in the English language.

  • Knowledge of medical and drug terminology desirable.Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.

  • Familiarity with ICH Guidelines.Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.

  • Ability to work independently with moderate supervision.

  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

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