About Hispanic Alliance for Career Enhancement
We unite caring with discovery to make life better for people around the world. As a global healthcare leader, we are headquartered in Indianapolis, Indiana. Our employees work together 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.
Our Mission:
To be a collaborative environment where diverse team members from 38 nationalities work together with benefits such as flexible hybrid working, healthcare, pension, onsite amenities, and holistic wellbeing initiatives.
We value diversity, equity, and inclusion (DEI), supporting all dimensions of identity and partnering with initiatives like EnAble to promote accessibility and inclusivity for all.
Job Summary:
This role involves operational execution related to safety data inputs, outputs, and oversight, including data collection, safety reporting, and performance monitoring. Responsibilities vary based on business needs and supervisor assignments.
Main Responsibilities:
* Apply clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems, ensuring integrity, consistency, and compliance.
* Expand knowledge of Lilly products, clinical trial design, safety profiles, and regulatory commitments.
* Develop expertise in case collection and expedited reporting requirements per agencies like FDA, EMA, MHRA, PMDA.
* Collaborate with GPS and clinical teams on various activities including case authoring, system maintenance, and trial closure.
* Prepare serious adverse event forms and support testing for Inform studies.
* Ensure data integrity through configuration and data flow management in systems like Mosaic PV and Inform.
* Provide device expertise, resolve CATool issues, and support product information updates.
* Support translation processes and share training on areas of proficiency.
* Participate in study teams and complete data reconciliation activities.
* Assist with system configuration and system issue resolution.
Quality, Compliance, and Operational Oversight:
* Ensure adverse event data management complies with standards and regulations.
* Conduct quality assessments and lead quality initiatives, including deviation and CAPA management.
* Review and analyze adverse event reports, determine reporting needs, and submit reports accordingly.
* Maintain and update procedures, provide training, and perform safety reporting activities.
* Monitor workflow and reporting metrics for compliance and performance.
* Manage external vendor activities related to safety data processing.
* Participate in audits and inspections, supporting EU QP responsibilities.
External Collaboration:
* Support activities for acquisitions and partnerships, including data migration and document review.
* Provide PV expertise to various internal teams and partners, ensuring efficient responsibilities execution.
* Engage in global projects and safety management improvements.
* Maintain understanding of PV agreements for assigned products.
Case Management Activities:
* Process adverse events from multiple sources, perform follow-up, and ensure data accuracy and completeness.
* Manage case data, including MedDRA coding, medical history, and medication details.
* Prioritize and manage workload to meet timelines.
Basic Requirements:
* Bachelor's degree or equivalent, healthcare or pharmaceutical science preferred.
* 3+ years in a similar role.
* Critical thinking, problem-solving, and decision-making skills.
* Proficiency with electronic systems and adaptability to new systems.
* Basic computer skills (word, spreadsheets, databases, search engines).
* Effective in a global team environment, understanding diversity and inclusion.
* Fluent in English (reading, writing, speaking).
Additional Preferences:
* Experience with PhV, global regulations, Argus safety database, or product complaint database.
We are committed to supporting individuals with disabilities. For accommodation requests, please complete the workplace accommodation form. We do not discriminate based on age, race, religion, gender, sexual orientation, or other protected statuses.