YOUR QUALIFICATIONS

• 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 ROLE

As a Global Safety Specialist, your focus will be on ensuring the processing and distribution of adverse event cases. You will be responsible for maintaining compliance with local legislations, safety data exchange agreements, and global ICSR regulations.

Conduct case triage and accurately enter case data into the database.

• Perform MedDRA and WHO Drug Dictionary coding of all cases.
• Write case narratives, establish listedness and causality assessments.
• Communicate with relevant stakeholders for follow-up information.
• Contribute to maintaining a strong medical device adverse event case handling process.
• Perform SAE reconciliation with data management/CROs.
• Act as the Global Safety Operations trial representative.
• Perform data validation of all cases according to source data.
• Ensure deviations and CAPAs are followed up on and closed in a timely manner.
• Establish communication with the PV organization internally and worldwide.
• Evaluate AEs and OEs received from customer/product complaints.