Team Lead Drug Safety Specialist

hace 4 días


Ciudad de México, Ciudad de México Novo Nordisk A tiempo completo
About the Role

We are seeking a highly skilled and experienced Team Lead Drug Safety to join our team in Mexico. As a key member of our Global Safety team, you will be responsible for driving the global strategy for culture, engagement, and performance management at Novo Nordisk.

Key Responsibilities
  • Ensure compliance with global drug safety legal requirements and guidelines, particularly concerning collection, collation, adverse event case entry, and other safety information relating to Novo Nordisk products reported from worldwide sources.
  • Manage the department, including coaching, mentoring, training, supporting direct reports, performance evaluation, development plan process, driving continuous improvements, contributing to setting the direction for Global Safety Mexico, and participating in cross-functional team projects.
  • Manage the team to ensure quality, compliance, and efficiency targets are met. Improve the efficiency of the team and oversee the day-to-day operations of the team.
  • Closely co-operate with other groups in Global Safety. Liaise with the Safety Reporting and IT in all aspects of E2B reporting; database and application management; data retrieval; custom reporting.
  • Provide input to safety data exchange agreements and pharmacovigilance system description documents regarding the post-marketing surveillance process.
Requirements
  • Bachelor's degree is required. An educational background as a B. Pharm / B.D.S / M. Pharm / Life sciences is preferred.
  • A minimum of 8-9 years of experience in the pharmaceutical industry/Pharmacovigilance/Contract research organizations (CROs), including a minimum of 2 or more years of management experience with good people skills.
  • Solid knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety.
  • Should have a global mindset and enjoy building relations across organisational levels and geography learn and adapt quickly.
  • Excellent oral and written English communication skills.
About the Department

The position is based in Mexico and reports to the Department Head of the affiliate support function. Our team is dedicated to ensuring regulatory compliance and safeguarding patients by making sure our medicines are safe to use. We work closely with Global Safety Bangalore and SO-DK, and our collaborative environment is fast-paced and dynamic. A certain amount of international travel is required for training purposes, collaboration, and/or management meetings.

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 69,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.


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