Primary Responsibilities
- Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance.
- Continuously expand knowledge of Lilly compounds / products (e.g., design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities).
- Continuously expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
- Participates as a cross functional team member of study teams, as assigned
- Understand functioning of systems owned GPS (e.g., MOSAIC, LSS), contributing with updates / enhancements and solution of workflow issues
- 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.
- 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:
- Master’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)