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Case Management Associate-Fixed Duration Employment
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The purpose of the Associate/Senior Associate/Associate Consultant Case Management (Case Manager) role is responsible for adverse event report handling. This includes assessing and processing individual adverse event reports; maintaining awareness of global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners; as well as other duties as assigned. An associate's responsibilities can vary depending on the needs and focus of a particular team as well as the global case manager competency model.
I. Adverse Event Case Management
Responsible for review, entry, assessment, and acknowledgement of adverse event reports in the safety database
Responsible for the completeness and accuracy of data co,llection and entry, case assessment, and other associated case management activities ·
Identifies issues in case processing that may result in a delay in mailing and escalates issues to management as appropriate
Develop an understanding/expertise of pharmacovigilance regulations
Comply with internal and external timelines for managing adverse event data entry, expedited reporting processes as appropriate
Typical case management processing activities include (but not limited to):
Validate/perform data entry against source document(s) as appropriate
Creation of a case narrative
Route case to safety physician for medical review when necessary
Identify concomitant medications and relevant medical history
Additional case management activities may include (but not limited to):
Completion of case management activities related to business partnerships as necessary
Review and analyze individual adverse event reports to establish need to report to local regulatory authorities, and submit as necessary, in accordance to local regulations and internal procedures
Perform a review for medical accuracy, completeness, consistency, and adherence to GPS standards
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):
Perform initial review of safety data for completeness and technical accuracy
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
Global GPS Support
Keep current on global regulatory issues and practices related to GPS
Understand and apply GPS business practices
Develop and update GPS standard operating procedures and training tools/programs as necessary
Support Affiliates, Business Units, and Center of Excellence in GPS related activities as necessary
Develop therapeutic area focus, liaise with members of the therapeutic team (e.g for ClinicalTrial case managers- provide safety related support to the development teams)
Partner and communicate with GPS Surveillance colleagues
Understand the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (EU QPPV) and ensure support is provided to fulfill the EU QPPV legal responsibilities.
Mentor and coach less experienced staff
Collaboration/Support Internal and External Customers
Communicate effectively with Lilly Corporate contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups
Provide support to Affiliate, Business Unit, and Center of Excellence personnel on GPS practices related to the management of adverse event reports
Understand the confidential nature of company information and take necessary steps to ensure its protection
Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties
May be required to author the ERB line listings for Investigator line listings with input from medical, toxicology, surveillance, and GPS medical
Bachelor's Degree (or higher) in a healthcare-related field or life sciences field
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Demonstrates basic clinical knowledge of various disease states
Effective communication skills (verbal and written)
Demonstrates competency in IT platforms including databases, Microsoft Office, and Lilly 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
Project Management skills
Proven Leadership (i.e. working autonomously, influencing without authority, ability to network ideas in corporate environment)
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
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.