Safety Operations Advisor 1

Novo Nordisk; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Novo Nordisk invites applications for a Safety Operations Adviser in Bengaluru. You will evaluate adverse events from worldwide sources, perform causality assessments, and ensure regulatory reporting across trials and marketed products.

You will collaborate with clinical teams, lead safety meetings, and mentor partners on MedDRA coding and safety data handling in a global pharmacovigilance framework.

Qualifications

• Medical degree with pharmacovigilance knowledge.
• Documented experience in drug safety evaluation and regulatory compliance.

Responsibilities

• Conduct medical interpretation of adverse events from global sources.
• Ensure timely reporting of serious adverse events to health authorities.
• Perform medical reviews and causality assessments for safety signals.
• Collaborate with clinical project teams to address safety aspects.
• Lead cross-functional safety meetings to standardize case handling.

Skills

MBBS

Pharmacovigilance

Drug safety

Causality assessment

ICH-GCP

English fluency

Regulatory compliance

Education

MBBS or equivalent

Job description

Company: Novo Nordisk, Global Business Services; Department: Safety Operations, Global Patient Safety; Location: Bangalore, India

Protect patients worldwide by ensuring the highest standards of drug safety - where your medical expertise directly impacts millions of lives.

Your new role

As a Safety Operations Adviser, you'll play a critical role in safeguarding patients by ensuring the comprehensive evaluation and reporting of adverse events from clinical trials and marketed products worldwide. Your medical expertise will be essential in maintaining Novo Nordisk's commitment to patient safety and regulatory excellence.

Day-to-day Your Responsibilities Will Include

• Conducting thorough medical interpretation and evaluation of adverse events reported from worldwide sources, including clinical trials and post-marketing surveillance


• Ensuring compliance with global regulatory requirements for the collection, evaluation, and expedited reporting of serious adverse events to health authorities


• Performing medical reviews and causality assessments of serious adverse events, determining potential relationships to Novo Nordisk products


• Participating in clinical project teams to ensure all safety aspects are appropriately addressed from protocol design through trial conduct


• Leading cross-functional groups and chairing safety meetings to drive consistency in case handling across projects and geographies


• Establishing improved methods and sharing best practices to enhance safety deliverables and ensure accurate MedDRA coding


• Training investigators, clinical safety associates, and affiliate partners on safety data handling and adverse event management

Your new department

You'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. Within Global Patient Safety, the Safety Operations Advisers team serves as the medical backbone of our pharmacovigilance operations. Working across time zones and therapy areas, our team collaborates closely with Global Development, Regulatory Affairs, Data Management, and affiliates worldwide to ensure every adverse event is expertly evaluated and reported. Your role will directly contribute to maintaining the highest safety standards for the millions of patients who depend on our medicines.

Your Skills & Qualifications

• Medical degree (MBBS or equivalent) with postgraduate medical qualification preferred


• Documented experience in drug safety evaluation, pharmacovigilance, or pharmacoepidemiology with strong knowledge of international regulatory requirements (ICH-GCP, EMA, FDA guidelines)


• Comprehensive understanding of clinical manifestations, disease management, and medical treatment across various therapeutic areas


• Proven ability to perform independent medical causality assessments and make critical decisions regarding drug safety issues


• Strong analytical and systematic approach with excellent attention to detail and ability to work under tight regulatory timelines


• Fluency in English (written and spoken) with excellent communication skills for collaborating across cultural and linguistic differences


• Self-motivated team player with flexibility to manage multiple priorities and ability to train and mentor others

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. In patient safety, this commitment takes on even greater significance - your expertise directly protects the patients who trust our medicines. When you join us, you're not just starting a job - you're becoming part of a story that spans generations.

What We Offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. You'll have access to continuous professional development, international exposure, and the chance to work with cutting-edge safety systems and methodologies in one of the world's leading pharmaceutical companies.

Deadline

5th october 2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.