Job Description

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 35,000 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.

Purpose:

The role based in LCCI GPS (Lilly Capabilities Centre India, Global Patient Safety) 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. The responsibilities can vary depending on the needs and focus of a particular team.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Safety Management activities (as assigned):

• Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, Lilly Market Research, literature, spontaneous reports, etc.).
• Assess individual reports identifying gaps of information and the need to conduct follow-up to clarify seriousness, expectedness, causality and achieve case completion.
• Comply with internal and external timelines for managing adverse event data entry.
• Lead/support literature search strategy updates and system issues/enhancements.
• Translate global / regional / local PhV regulatory requirements into expedited reporting rules and conduct Product License studies activities.
• Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities. These activities may include but are not limited to:

• Management of adverse events arising from various sources including but not limited to literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous, pregnancy, devices, Lilly Market Research (LMR), etc.
• Ensure the following: appropriate serious outcome criteria for adverse events are selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review.
• Complete or verify MedDRA coding.
• Identify concomitant medication and relevant medical history.

• Ensure appropriate Follow Up is obtained utilizing a customer experience mindset whether working with patients, HCPs, or investigators/site personnel.
• Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues.
• Prioritize work to ensure internal and regulatory timelines are met.

Quality, Compliance and Operational Oversight

• Provide oversight to ensure that adverse event data is managed appropriately to internal standards and external regulations.
• Conduct quality assessments defined in prevailing procedures (e.g., peer review of individual cases, aggregate review of cases in PhV queries) and drive quality initiatives.
• Responsible for leading and/or addressing quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the safety reporting process.
• Review and analyze individual adverse event reports to establish need to report to regulatory authorities, and submit as necessary, in accordance with applicable regulations and internal procedures.
• Act as subject matter expert for the creation, revision and maintenance of procedures and resources, sharing expertise and providing training when required.
• Perform safety reporting within relevant processes and timelines (e.g., expedited, and periodic).
• Oversee safety reporting schedules and maintain metrics for compliance reporting.
• Oversee external collaborators/vendors to support quality and timely processing of adverse events from clinical trial, literature, and spontaneous sources.
• Perform timely monitoring of workflow and reporting parameters to ensure compliance with regulations and performance metrics.
• Review and action deletion request reviews.
• Perform User acceptance testing in system environments.
• Contribute with configuration, enhancement, and maintenance of automated activities related to case intake, data entry, expedited reporting, and operational oversight.
• Participate with internal audits and inspections to ensure accurate information is provided as needed.
• Understand the roles of the EU qualified person (QP) and ensure support is provided to fulfill the QP legal responsibilities.

External Collaboration

• Support activities related to new acquisitions and business alliances (e.g., case exchange, data migration quality verifications, document review, etc.).
• Provide expertise in PV knowledge of individual case processes and requirements to other functions within GPS and Lilly to ensure efficiency in execution of responsibilities.
• Provide PV expertise to support Affiliates, and Business Units, Medical, and Call Centers in GPS related activities, as necessary.
• Partner to provide expertise and communicate with colleagues including but not limited to Surveillance, Medical, Pharmacoepidemiology, Data Management, Business Alliance, Corporate, Quality and Legal.
• Be a pro-active and consistent member of medical team meetings. Provide individual case knowledge to facilitate reconciliation and trial data completion.
• Provide expertise and authoring of ERB line listings or Investigator line listings with input from medical, toxicology, surveillance, and GPS medical.
• Provide expertise for the process flow for receiving serious adverse event data and changes or discoveries during studies.
• Liaison with Business Alliance for business partner, issues, review of safety agreements, process changes required to ensure business continuity.
• Be a pro-active member providing expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements.
• Maintain understanding of PV agreements for assigned products.

Minimum Qualification Requirements:

• Bachelor's degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science preferred.
• Critical thinking to solve problems, and make decisions autonomously, and as part of a team.
• Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems.
• Basic computer skills (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines).
• Ability to work effectively in a global team and apply understanding of diversity and inclusion.
• Fluency in English (write / read / speak)

• 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.

Other Information/Additional Preferences:

• Demonstrated PhV experience
• Knowledge of global regulations with respect to adverse event reporting for both drugs and devices.
• Project Management skills.
• Proven Leadership (i.e. working autonomously, influencing without authority, ability to network ideas in corporate environment).
• Demonstrated interpersonal skills; ability to work as part of a team.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

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