Global Safety Operations Specialist

4 days ago


Copenhagen, Copenhagen, Denmark LEO Pharma Full time

Role Overview

Leverage your expertise in pharmacovigilance and safety data management to drive compliance and maintain high standards in adverse event case management. As a Global Safety Specialist at LEO Pharma, you will play a critical role in ensuring the processing and distribution of adverse event cases.

Key Responsibilities

  1. Conduct thorough case triage and accurately enter case data into the database.
  2. Perform MedDRA and WHO Drug Dictionary coding of all cases.
  3. Write concise case narratives and establish listedness and causality assessments.
  4. Communicate effectively with relevant stakeholders for follow-up information.
  5. Contribute to maintaining a robust medical device adverse event case handling process.
  6. Perform SAE reconciliation with data management/CROs.
  7. Act as the Global Safety Operations trial representative.
  8. Data validation of all cases according to source data.
  9. Ensure deviations and CAPAs are followed up on and closed in a timely manner.
  10. Evaluate AEs and OEs received from customer/product complaints.

About You

  • University degree in health or life science with a minimum 2 years of experience in Pharmacovigilance and/or Safety Data Management.
  • Strong computer literacy and knowledge of safety databases.
  • Understanding of EMA/ICH/FDA guidelines.
  • Ability to analyze and interpret data.
  • High level of accuracy, integrity, and quality in work practices.
  • Excellent communication skills, both oral and written.

Your New Team

We value a collaborative atmosphere where you can reach out to a colleague or manager for support and sparring. This is a unique chance to gain valuable experience and make a significant impact in a short period while contributing to our mission and building a strong foundation for your career.



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