Team Lead Drug Safety- GBS

Category: Clinical Development

Location:Ciudad de México, Ciudad de México, MX

• 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.
• Close co-operation 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.

• 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.