Drug Safety Associate

Company: Eli Lilly

Industry: Private

Employment Type:- Full Time

Work Hours:-  8 Hours

Locations:- USA

Full Job Description:-

Welcome to Eli Lilly and Company, a leading pharmaceutical company dedicated to improving the lives of patients around the world. We are currently seeking a highly motivated and detail-oriented Drug Safety Associate to join our team.As a Drug Safety Associate, you will play a crucial role in ensuring the safety and efficacy of our products. You will be responsible for monitoring and reporting adverse events associated with our medications, as well as implementing risk management strategies and collaborating with cross-functional teams.To excel in this role, you must have a strong understanding of drug safety regulations and guidelines, excellent communication and organizational skills, and the ability to work independently and in a team. A degree in a relevant scientific field and prior experience in pharmacovigilance is required.If you are passionate about patient safety and making a positive impact in the pharmaceutical industry, we encourage you to apply for this exciting opportunity at Eli Lilly and Company. Join us in our mission to make life better for people around the world.

  • Monitor and report adverse events associated with our products to ensure compliance with drug safety regulations and guidelines.
  • Implement risk management strategies to minimize potential safety concerns.
  • Collaborate with cross-functional teams including pharmacovigilance, clinical development, regulatory affairs, and medical affairs.
  • Conduct thorough and timely review of safety data from clinical trials, post-marketing surveillance, and literature.
  • Communicate safety updates and findings to internal stakeholders and regulatory authorities.
  • Develop and maintain drug safety databases and ensure accurate and timely data entry.
  • Participate in the development and maintenance of drug safety policies and procedures.
  • Stay updated on current drug safety regulations and guidelines to ensure compliance.
  • Conduct periodic safety reviews and signal detection activities to identify potential safety issues.
  • Provide support for safety-related inquiries from healthcare professionals and patients.
  • Represent the company in safety-related meetings and discussions with external partners.
  • Maintain confidentiality and adhere to ethical standards when handling sensitive safety information.
  • Work independently and in a team to meet project deadlines and goals.
  • Maintain accurate and organized records of safety data and activities.
  • Contribute to continuous improvement efforts within the drug safety department.

Job Qualifications

  • Knowledge Of Fda Regulations And Guidelines Related To Drug Safety And Adverse Event Reporting.
  • Bachelor’s Degree In A Scientific Field Such As Pharmacy, Nursing, Or Biology.
  • Previous Experience In Pharmacovigilance Or Drug Safety, Preferably In A Pharmaceutical Company.
  • Excellent Communication And Organizational Skills, With The Ability To Effectively Communicate Complex Scientific Information.
  • Familiarity With Pharmacovigilance Databases And Adverse Event Case Management Systems.

Required Skills

  • Risk Management
  • Medical Terminology
  • Regulatory compliance
  • Adverse Event Reporting
  • Signal Detection
  • Case Processing
  • Drug Safety Databases
  • Pharmacovigilance Management
  • Adverse Event Coding
  • Safety Signal Assessment

Soft Skills

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  • Problem-Solving

Drug Safety Associate

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