Global Safety Operations Specialist
4 days ago
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
- Conduct thorough case triage and accurately enter case data into the database.
- Perform MedDRA and WHO Drug Dictionary coding of all cases.
- Write concise case narratives and establish listedness and causality assessments.
- Communicate effectively with relevant stakeholders for follow-up information.
- Contribute to maintaining a robust medical device adverse event case handling process.
- Perform SAE reconciliation with data management/CROs.
- Act as the Global Safety Operations trial representative.
- Data validation of all cases according to source data.
- Ensure deviations and CAPAs are followed up on and closed in a timely manner.
- 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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