Patient Safety Senior Associate
hace 2 meses
As a Patient Safety Senior Associate at Novo Nordisk, you will play a critical role in ensuring the safety and efficacy of our products. Your primary responsibilities will include:
- Receipt, documentation, and quality assessment of inbound safety information, including adverse events and technical complaints.
- Ensuring compliance with all internal and external drug and device safety reporting requirements.
- Duplicate searches, product coding, and narrative generation.
- Handling inbound and outbound calls and correspondence for adverse events and technical complaints.
- Providing professional and timely responses to product information questions and inquiries.
- Assisting with training and mentoring of new joiners and workload distribution and coordination.
- Identifying opportunities for development of procedures and making recommendations to management.
Requirements
- Bachelor's degree in a science or healthcare discipline.
- 3+ years of patient safety experience, preferably with customer service experience.
- Strong knowledge of medical and pharmacovigilance terminology.
- Experience with MedDRA coding and adverse event identification is preferred.
- Advanced or Fluent Level of Spanish and English.
- Familiarity with FDA regulations, computer validation, and Sarbox regulatory requirements.
- Proficiency in test case writing and execution is a must.
About the Department
The Clinical, Medical & Regulatory department at Novo Nordisk is dedicated to ensuring the safety and efficacy of our products. We work closely with healthcare professionals, patients, and regulatory authorities to collect and analyze safety information.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a legacy of driving change to defeat serious chronic diseases. We are growing and expanding our commitment to reach millions around the world and impact more than 40 million patient lives daily. Our success relies on the joint potential and collaboration of our employees around the world.
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