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:
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

The base pay for this position is

N/A

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

Medical Writing

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : Mumbai Development Center - EPD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Required Experience:

IC