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Associate/ Senior Associate - Safety Management

0-5 years
Not Disclosed
10 May 15, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview:

Eli Lilly and Company, headquartered in Indianapolis, Indiana, is a global healthcare leader dedicated to improving the lives of people worldwide. With a focus on discovering and delivering life-changing medicines, Lilly employees around the globe work tirelessly to enhance disease understanding, manage conditions effectively, and contribute to communities through philanthropy and volunteerism. Committed to putting people first, Lilly seeks individuals determined to make a positive impact on a global scale.

Primary Responsibilities:

  1. Apply clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems, ensuring data integrity, consistency, and compliance.
  2. Expand knowledge of Lilly compounds/products, including clinical trial design, safety profile, regulatory commitments, indications, identified risks, adverse reactions, and risk minimization activities.
  3. Stay updated on case collection and expedited reporting requirements by major regulatory agencies (FDA, EMA, MHRA, PMDA).
  4. Participate as a cross-functional team member in study teams as assigned.
  5. Understand the functioning of GPS-owned systems (e.g., MOSAIC, LSS), contribute updates/enhancements, and resolve workflow issues.
  6. Process adverse events and safety information from various sources (e.g., Clinical Trials, Patient Support Programs, literature, spontaneous reports).
  7. Assess individual reports, identify information gaps, and conduct follow-up to clarify seriousness, expectedness, and causality.
  8. Adhere to internal and external timelines for adverse event data entry.
  9. Lead/support literature search strategy updates and system issues/enhancements.
  10. Translate global/regional/local pharmacovigilance regulatory requirements into expedited reporting rules and conduct Product License studies activities.
  11. Ensure completeness and accuracy of data management within GPS Systems and associated case management activities.
  12. Complete or verify MedDRA coding, identify concomitant medication and relevant medical history, and ensure appropriate follow-up.
  13. Prioritize work effectively to meet internal and regulatory timelines.
  14. Provide expertise on local or global projects to ensure consistent innovation and improvements in Safety Management.
  15. Maintain understanding of pharmacovigilance agreements for assigned products.

Minimum Qualification Requirements:

  • Master's degree or equivalent experience, preferably in healthcare or pharmaceutical/biological science.
  • Strong critical thinking skills to solve problems and make decisions autonomously or as part of a team.
  • Ability to adapt to and utilize electronic systems effectively.
  • Basic computer skills (word processing, spreadsheets, presentations, databases).
  • Ability to work collaboratively in a global team, embracing diversity and inclusion.
  • Fluency in English (written, spoken, and reading).

Additional Information:

Lilly is committed to ensuring equal opportunities for individuals with disabilities to participate in the workforce. If accommodation is required to submit a resume for positions at Lilly, applicants can email Lilly Human Resources for assistance. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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