case management associate

Job Description Job Title: Case Management Associate

Job Duration: 18 months +

Job Location: Indianapolis, IN, United States

Job Details: Manage adverse event reporting. Stay current regarding FDA and global regulations with respect to safety reporting and pharmacovigilance. Ensure regulatory compliance for expedited submission of case reports. Maintain an understanding of current labeling practices (e.g., USPI, Core, CIP and EUSPC). Interact with internal and external customers. Provide support regarding Global Product Safety (GPS) policies, processes and procedures. Support product safety surveillance activities.

Qualifications Bachelor's degree (or higher) in a healthcare-related field or life sciences field or demonstrated equivalent experience is required

Demonstrates basic clinical knowledge of various disease states

Effective communication skills (verbal and written)

Demonstrates competency in IT platforms including databases, Microsoft Office, and CLIENT web based collaboration sites

Ability to manage multiple concurrent tasks; good organizational skills, attention to detail; ability to focus for long periods of time on detailed information; consistently prioritizes work and makes decisions that comply with applicable timelines

Effectively analyzes possible solutions to solve a range of problems

Effectively responds to customer requirements and requests

English language skills — fluent written and verbal communications

Knowledge of global regulations with respect to adverse event reporting

Knowledge and understanding of GPS policies and procedures

Ability to learn quickly and adapt to a changing environment

Flexibility to adapt to changing priorities

Demonstrated interpersonal skills; ability to work as part of a team

Ability to see the big picture; use logic to solve problems

Responsibilities Responsible for review, entry, assessment, and acknowledgement of adverse event reports in the safety database

Develop an understanding/expertise of pharmacovigilance regulations

Comply with internal and external timelines for managing adverse event data entry and expedited reporting processes as appropriate

Creation of a case narrative

Attempt to obtain follow-up information from external parties through effective written and oral communications

Perform typical case management assessment activities which include (but not limited to): select individual adverse event terms; code events to appropriate MedDRA terms; manage and assess appropriate serious outcome criteria for adverse events; assess listedness - evaluate the case against the appropriate product information; determination of whether medical physician safety review is necessary; determine what, if any, follow-up information is needed

Keep current on global regulatory issues and practices related to GPS

Understand and apply GPS business practices

Collaborate with internal and external customers

Communicate effectively with CLIENT Corporate contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups

Understand the confidential nature of company information and take necessary steps to ensure its protection

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