(Sr) Patient Safety Specialist

Job description

Main job tasks

• 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
• 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
• 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
• 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
• 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 Qualifications: Education -Master’s degree in Pharmacy, Life Sciences, or a related field is preferred. Experience -1-5 years of experience in pharmacovigilance or drug safety is preferred.
• Familiarity with clinical trials and post-marketing safety programmes.
• With the pharmaceutical industry experience is preferred.
• Good command of written and spoken English. Professional working proficiency in English, with the ability to communicate effectively with stakeholders.

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