Pharmacovigilance Safety Surveillance Specialist

Novo Nordisk India Pvt Ltd; Bengaluru; Sur place; INR 1 400 000 - 2 100 000; Plein temps

Résumé du poste

Novo Nordisk India Pvt Ltd in Bangalore seeks a Safety Surveillance Specialist to safeguard the safety profile of our diabetes, obesity and rare disease products. You will translate complex data from trials, reports and literature into clear safety signals and strategic actions, guiding risk management across product lifecycles.

You are a physician with deep pharmacovigilance experience, proficient in English, and skilled at leading safety governance discussions with regulators and partners in a

Qualifications

• Medical degree (MBBS or MD) from an accredited institution.
• Minimum 12 years in pharmacovigilance or patient safety.
• Experience in signal management, risk management plans (RMPs) and aggregate safety reports.
• Strong understanding of drug development and regulatory frameworks.
• Ability to interpret epidemiological data and integrate diverse evidence.
• Strong project and stakeholder management skills.
• Excellent written and spoken English.
• Innovative mindset with track record of contributing to long-term strategy and process improvements.

Responsabilités

• Accountable for the medical safety evaluation of products from clinical development through to the market, turning complex data into clear decisions and documented conclusions.
• Establish and maintain the product safety profile through critical safety data analysis, including signal detection, evaluation and expert interpretation of literature.
• Lead pharmacovigilance planning by developing and executing safety strategies to evaluate safety issues throughout the product lifecycle.
• Provide expert opinion on benefit-risk assessments and contribute to risk management strategies.
• Contribute to clinical study designs and the safety monitoring strategy of study protocols.
• Support the development and maintenance of core reference safety information, take part in product labelling and make sure safety interpretation and conclusions are accurately documented in regulatory reports.
• Establish and contribute to safety governance meetings, and represent Safety Surveillance in discussions with regulatory authorities, external consultants and partners.

Connaissances

Pharmacovigilance

Signal management

RMPs (risk management plans)

Epidemiology data interpretation

Project management

Stakeholder management

English communication

Strategic thinking

Formation

MBBS/MD

Description du poste

Safety Surveillance Specialist

Department: Global Patient Safety, Novo Nordisk Global Business Services (GBS)

Location: Bangalore, Novo Nordisk Global Business Services (GBS), India

Your impact begins here

As Safety Surveillance Specialist, you will help establish and protect the safety profile of Novo Nordisk products across Diabetes, Obesity and Rare Diseases. You will turn data from clinical trials, spontaneous reports, literature and post-marketing sources into clear signals, safety strategies and benefit-risk conclusions. Your medical judgement will help identify concerns early and keep safety information accurate throughout each product’s lifecycle – so people living with serious chronic diseases, and those who treat them, can rely on it. You are a physician with deep pharmacovigilance experience who is ready to shape safety strategy, not only apply it.

If you are ready to lead safety surveillance that people living with serious chronic diseases can rely on,

You will bring:

• A medical degree (MBBS or MD) from an accredited institution.
• A minimum of 12 years in pharmacovigilance or patient safety, with proven delivery.
• Extensive experience in signal management, risk management plans (RMPs) and aggregate safety reports.
• A strong understanding of drug development and regulatory frameworks.
• The ability to interpret epidemiological data and bring different sources of evidence together into sound conclusions.
• Strong project and stakeholder management skills.
• Excellent written and spoken communication skills, with fluency in English.
• An innovative mindset, with a track record of contributing to long‑term strategy and process improvements.

What you’ll do

• You will be accountable for the medical safety evaluation of products from clinical development through to the market, turning complex data into clear decisions and documented conclusions.
• Establish and maintain the product safety profile through critical safety data analysis, including signal detection, evaluation and expert interpretation of literature.
• Lead pharmacovigilance planning by developing and executing safety strategies to evaluate safety issues throughout the product lifecycle.
• Provide expert opinion on benefit-risk assessments and contribute to risk management strategies.
• Contribute to clinical study designs and the safety monitoring strategy of study protocols.
• Support the development and maintenance of core reference safety information, take part in product labelling and make sure safety interpretation and conclusions are accurately documented in regulatory reports.
• Establish and contribute to safety governance meetings, and represent Safety Surveillance in discussions with regulatory authorities, external consultants and partners.

Who you’ll work with

You will join the Safety Surveillance Adviser team in Global Patient Safety in Bangalore, part of Novo Nordisk Global Business Services. The team monitors, evaluates and communicates the safety profile of Novo Nordisk products across their lifecycle, contributing to safety surveillance across the Diabetes, Obesity and Rare Diseases portfolios. You will work closely with global hubs in Copenhagen and other partner teams, as well as colleagues across functions in a matrix environment. Externally, you will engage with regulatory authorities, consultants and partners on safety-related topics. Building strong relationships across these groups helps the team act on signals quickly and speak with one clear voice on safety. You will also coach and mentor team members, sharing your expertise to raise the capability of the team around you.

What you can expect here

You will work on medicines used by many people around the world, where your medical expertise directly shapes how safety is assessed, managed and communicated. You will be trusted to own your conclusions, make your voice heard in governance and regulatory discussions and help decide how the team works – from strategy to process improvements. We care for people and never compromise on patient safety. At the same time, we calibrate our standards to the situation and act with clarity and urgency, so safety insights lead to timely decisions. You will grow alongside experienced colleagues in Bangalore and Copenhagen, and help others grow through coaching and mentoring.

Experience Level Mid Level

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