Job Description: Safety Operations Specialist I
Location: Bangalore, India
Job Category: Reg Affairs & Safety Pharmacovigilance
Novo Nordisk is a global healthcare leader, recognized for driving change in chronic disease treatment. We are expanding rapidly and impacting millions of lives worldwide. Join us in our mission to create life-changing solutions!
As a Safety Operations Specialist I at Novo Nordisk, you will play a critical role in ensuring the safety of medicinal products. This position will involve handling adverse events, ensuring compliance with global regulatory requirements, and leading cross-functional projects. You will also be responsible for supporting the implementation of processes and requirements driven by increasing regulatory demands.
Process Improvement & Best Practices: Establish new or enhanced methods within your field of expertise, ensuring consistency in safety deliverables and providing qualified support to the business.
Safety Data Handling: Manage adverse events and safety information to ensure global regulatory compliance.
Project Management: Lead and define project scope, goals, deliverables, and stakeholder mapping across functional areas.
Deviation & Change Management: Own the deviation and change request process, including reporting, investigations, and corrective/preventive action decision-making.
Audit & Inspection Support: Review safety data in relation to audits and inspections, ensuring global safety processes are followed.
Collaboration: Work with affiliates to implement new processes and regulatory requirements as they arise.
Education: Graduation or post-graduation in life sciences.
Experience: At least 6 years of relevant experience in pharmacovigilance with extensive knowledge of safety information handling.
Skills:
The Global Safety - Global Business Services (GS-GBS) team, established in 2010, is responsible for safety case processing, medical review, safety report submission, and more. The team plays an essential role in ensuring safety across the organization by providing oversight on literature surveillance, quality control, and training activities.
At Novo Nordisk, we aim to be the best company for the world by driving innovations in healthcare and improving the lives of millions. Join us in this endeavor and work alongside a team of talented professionals committed to making a real-world impact.
To apply, submit your CV online by following the instructions.
10th January 2025.
Disclaimer:
Beware of fraudulent job offers pretending to be from Novo Nordisk. We do not extend unsolicited job offers or charge fees in the recruitment process.
Novo Nordisk values diversity and strives to create an inclusive environment for all employees, patients, and the communities we serve. We believe that diversity brings strength, and together, we can achieve life-changing results.
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