Lilly Hiring Biological Sciences For Intern Opportunity – Apply Online

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.

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:  

• 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)

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 ( [email protected] ) 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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Interview Questions:

1. How would you ensure data integrity, consistency, and compliance while managing adverse event data within GPS systems? Answer: I would apply clinical judgement and critical thinking to assess the adverse event data, ensuring the accuracy of information, appropriate coding, and adherence to regulatory requirements. Continuous learning about Lilly compounds and regulatory commitments would help in making informed decisions.
2. Can you describe the process of expedited reporting for adverse events as required by major regulatory agencies like FDA, EMA, MHRA, PMDA? Answer: Expedited reporting involves timely submission of adverse event data to regulatory agencies. Understanding the specific reporting requirements for each agency and coordinating with cross-functional teams will facilitate efficient reporting and compliance.
3. How would you handle adverse event cases that lack complete information, such as seriousness, expectedness, and causality? Answer: In such cases, I would initiate follow-up communication with the relevant stakeholders, such as patients, healthcare professionals, or investigators, to gather the missing information. The aim is to ensure comprehensive and accurate case completion for medical review.
4. How do you prioritize and manage incoming work to meet internal and regulatory timelines for adverse event data entry? Answer: Prioritizing work based on urgency and collaborating with global colleagues for workload distribution will help me meet internal and regulatory deadlines. Adapting to changing systems and employing critical thinking will aid in effective time management.
5. As a Junior Drug Safety Associate, how would you contribute to the innovation and improvement of Safety Management processes? Answer: I would actively participate in local and global projects, providing expertise and suggestions for enhancing Safety Management practices. Emphasizing a customer-centric approach and staying updated with PV agreements for assigned products will ensure continuous improvements.

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