(Sr) Patient Safety Specialist

Job description

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 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. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.