Case Processing Specialist

Job Description

Primary Job Function:
The position holder is responsible for the prioritization and full case processing of spontaneous ICSRs and solicited ICSRs received from non-interventional organized data collection schemes (NIODCS) reported in association with Abbott products, including those received from external stakeholders, e.g. regulatory authorities, investigator initiated studies and co-licensing partners.

Core Job Responsibilities:
Responsibilities include but are not limited to:
u2022 Triage and prioritization of ICSRs received for Abbott products worldwide and for ICSRs from Abbott sponsored studies, study cases from license partners and from Literature in line with applicable regulations and Abbott Standard Operating Procedures (SOPs) and Work Instructions (WIs)
u2022 Full case processing of spontaneous ICSRs and solicited ICSRs received from NIODCS in required timelines
u2022 Perform medical review and determine company causality for certain solicited ICSRs
u2022 Code adverse events, indications of suspect and concomitant medications, medical history and laboratory investigations as per MedDRA coding conventions
u2022 Perform a verification of the case data and finalize the case version
u2022 Determine and perform appropriate case follow-up, including the generation of follow-up queries & clarifications, as required
u2022 Perform case amendments or deletions if requested
u2022 Perform late case investigations and propose corrective and preventive actions
u2022 Support of reconciliation/replenishment and data clean-up activities
u2022 Support projects related to safety database updates, data migration activities or the like
Support the maintenance and updates of Case Management quality documents (e.g. SOPs and WIs)

Supervisory/Management Responsibilities:
Direct Reports: none
Indirect Reports: none
Position Accountability/Scope:
u2022 Full case processing of spontaneous ICSRs and solicited ICSRs received from NIODCS in line with applicable timelines, regulations and Abbott SOPs and WIs
u2022 Works with supervision and guidance
Minimum Education:
u2022 Degree in life sciences, nursing, information management or comparable education
u2022 Good command of the English language
Minimum Experience/Training Required:
u2022 Practical experience in ICSR processing minimum 2 years, preferably more
u2022 Experienced professional in the usage of Microsoft Office
u2022 Experience in the usage of Drug Safety databases preferred and medical coding experience preferred
u2022 Training according to assigned ISOtrain curriculum