Associate / Sr. Associate - Medicines Quality Organization (Pharmacovigilance)

at  Lilly

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 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.
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 patients around the world.
Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

AUDITS AND INSPECTIONS

• Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
• Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
• Ensure completion of audit corrective action plans and timely resolution.
• Leads and/or supports readiness activities in collaboration with business partners.

MINIMUM QUALIFICATION REQUIREMENTS

• Bachelor’s Degree in a science/health care related field or equivalent work experience
• Demonstrated ability to apply quality systems within a regulated work environment
• Strong understanding of pharmacovigilance regulations and guidelines.
• Effective project and time management skills
• Knowledge of GCP, ICH, FDA, and other regulatory requirements
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
• Effective organization/self-management skills

PURPOSE

The purpose of the Associate/Senior Associate – MQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas. Pharmacovigilance experience is essential to a successful candidate as they will be directly supporting the Safety Management group in Cork.

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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.