Drug Safety and Pharmacovigilance Advisor

Novo Nordisk India Pvt Ltd; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Novo Nordisk, Global Business Services in Bangalore, India, invites a Safety Operations Adviser to safeguard patients by ensuring comprehensive evaluation and reporting of adverse events from trials and marketed products worldwide. You will contribute to regulatory excellence and patient safety with medical expertise.

You will lead safety reviews, participate in clinical teams, and mentor colleagues while collaborating across time zones and therapy areas to maintain Novo Nordisk's high safety

Qualifications

• Medical degree (MBBS or equivalent) with postgraduate qualification preferred.
• Documented experience in drug safety evaluation, pharmacovigilance, or pharmacoepidemiology.
• Strong knowledge of international regulatory requirements (ICH‑GCP, EMA, FDA).
• Fluency in English, strong written and verbal communication.

Responsibilities

• Conduct medical interpretation and evaluation of worldwide adverse events from trials and post‑marketing surveillance.
• Ensure compliance with global regulatory requirements for collection, evaluation, and expedited reporting of serious adverse events to health authorities.
• Perform medical reviews and causality assessments of serious adverse events and their relation to Novo Nordisk products.
• Participate in clinical project teams to address safety aspects from design to trial conduct.
• Lead cross‑functional groups and chair safety meetings to drive consistency in case handling across projects and geographies.
• Establish improved methods and share best practices to enhance safety deliverables and MedDRA coding.

Skills

Medical degree

Postgraduate qualification

Drug safety evaluation

Regulatory requirements

Clinical knowledge

Communication

Team mentoring

Education

MBBS with postgraduate qualification

Job description

Safety Operations Advisor 1

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

We're looking for a medically qualified professional with strong drug safety expertise who thrives in a dynamic, international environment. You'll bring with you:

• 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.