【346367】(Sr) Patient Safety Specialist

Main job tasks

1. Conduct drug safety surveillance and adverse reaction assessments

• Monitor and evaluate adverse reaction reports to determine relatedness to Novo Nordisk products
• Perform follow-up activities to ensure comprehensive safety data collection

2. Ensure compliance with regulatory requirements

• Adhere to governmental regulations and company policies in all safety pharmacovigilance activities
• Support the resolution of legal liabilities related to drug safety

3. Provide safety support for clinical development teams

• Collaborate with clinical teams to address safety concerns during product development
• Offer expert advice on safety strategies and risk mitigation

4. Contribute to safety signal detection and risk management

• Analyse trends and identify potential safety signals for products throughout their lifecycle
• Participate in risk management assessments to ensure patient safety

5. Oversee safety in clinical trials and post-marketing programmes

• Monitor safety data from clinical trials and post-marketing activities and monitor PV Agreement suppliers through periodic compliance checks in scope of the PV Agreement
• Ensure robust safety oversight and reporting mechanisms are in place