Job Title: Associate/Senior Associate – Safety Management
Department: Research & Development
Employment Type: Full Time
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).
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).
* Participate as a cross‑functional team member of study teams, as assigned.
* Understand the 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.
* Manage the completeness and accuracy of data management within the GPS Systems and other associated case management activities, including:
o Management of adverse events arising from various sources including literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous reports, pregnancy, devices, Lilly Market Research (LMR), etc.
o Ensure appropriate serious outcome criteria for adverse events are selected, appropriate terms are chosen from source documents, listedness and relatedness are completed accurately, and cases are available for Medical Review.
o Complete or verify MedDRA coding.
o Identify concomitant medication and relevant medical history.
o Ensure appropriate Follow Up is obtained utilizing a customer experience mindset when working with patients, HCPs, or investigators/site personnel.
o Understand and proactively manage incoming work by prioritizing and collaborating with global colleagues.
o Prioritize work to ensure internal and regulatory timelines are met.
o Be a proactive member providing expertise on local or global projects to ensure Safety Management is consistently delivering innovation and improvements.
o Maintain understanding of PV agreements for assigned products.
Job Location: Bangalore, Karnataka, India
Job ID: R-59538
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