Abbott Spontaneous Case Processing Specialist in Mumbai, India

JOB DESCRIPTION:

Primary Job Function:

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

The position holder may additionally have the role Literature Analyst.

Core Job Responsibilities:

Responsibilities include but are not limited to:

  • Triage, prioritization and case registration 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

  • Perform Labeling as per labeling conventions

  • Code adverse events, indications of suspect and concomitant medications, medical history and laboratory investigations as per MedDRA coding conventions

  • Perform a quality check 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

  • Screening of scientific literature for safety information in the Literature Analyst Role

  • 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, preferable more

  • Experienced professional in the usage of Microsoft Office

  • Experience in the usage of Drug Safety databases, medical coding experience preferred

  • Training according to assigned ISOtrain curriculum

JOB FAMILY:

Product Development

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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