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:
- 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)
- Full case processing of spontaneous ICSRs and solicited ICSRs received from NIODCS in required timelines
- Perform medical review and determine company causality for certain solicited ICSRs
- Code adverse events, indications of suspect and concomitant medications, medical history and laboratory investigations as per MedDRA coding conventions
- Perform a verification of the case data and finalize the case version
- Determine and perform appropriate case follow-up, including the generation of follow-up queries & clarifications, as required
- Perform case amendments or deletions if requested
- Perform late case investigations and propose corrective and preventive actions
- Support of reconciliation/replenishment and data clean-up activities
- 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:
- Full case processing of spontaneous ICSRs and solicited ICSRs received from NIODCS in line with applicable timelines, regulations and Abbott SOPs and WIs
- Works with supervision and guidance
Minimum Education:
- Degree in life sciences, nursing, information management or comparable education
- Good command of the English language
Minimum Experience/Training Required:
- Practical experience in ICSR processing minimum 2 years, preferably more
- Experienced professional in the usage of Microsoft Office
- Experience in the usage of Drug Safety databases preferred and medical coding experience preferred
- Training according to assigned ISOtrain curriculum
