Are you passionate about pharmacovigilance and ensuring the safety of medicinal products? Novo Nordisk, a global healthcare leader, is hiring a Safety Operations Specialist I in Bangalore, India. If you have a strong background in pharmacovigilance, regulatory compliance, and a desire to make a global impact, this could be your next career move. Read on to learn more about this exciting opportunity and how to apply.
Job Description
Location: Bangalore, India
Category: Regulatory Affairs & Safety Pharmacovigilance
Department: Global Safety – Global Business Services (GS-GBS)
As a Safety Operations Specialist I at Novo Nordisk, you will play a critical role in ensuring the safety of medicinal products and compliance with global regulatory requirements. Your responsibilities will include:
- Handling adverse events and other safety information to meet global regulatory standards.
- Leading cross-functional projects by defining scope, goals, deliverables, and stakeholder mapping.
- Owning deviations and change requests, preparing reports, and driving corrective/preventive actions.
- Reviewing safety data for audits and inspections, and presenting global safety processes during audits.
- Collaborating with affiliates to implement new processes or requirements based on regulatory demands.
- Sharing best practices to improve workflows and ensure consistency in safety deliverables.
Qualifications
To be considered for this role, you should have:
- A graduation or post-graduation degree in life sciences.
- A minimum of 6 years of experience in pharmacovigilance.
- Extensive knowledge of pharmacovigilance principles, safety information handling, and GxP requirements.
- Experience in training, business process improvements, and working in international, diverse teams.
- A deep understanding of pharmaceutical company operations and scientific regulations/guidelines.
- Fluency in English (written and spoken).
About Novo Nordisk
Novo Nordisk is a global healthcare leader with a 100-year legacy of driving change to defeat serious chronic diseases. Known for our expertise in diabetes care, we are expanding our commitment to impact over 40 million patient lives daily. With a presence in more than 80 countries and a workforce of over 63,000 employees, we are dedicated to creating a inclusive culture that celebrates diversity and fosters innovation.
At Novo Nordisk, we believe in changing lives—not just for our patients but also for our employees. Join us to be part of a collective effort that goes beyond individual success.
About the Department
The Global Safety – Global Business Services (GS-GBS) team, established in 2010, is a hub for safety case processing. The team handles cases from various sources, including spontaneous reports, literature, solicited reports, and clinical trials. GS-GBS is also involved in safety report submissions, training, quality control, ARGUS configuration, and medical literature monitoring.
