Principal Specialist, PV Proc Excellence

Novo Nordisk A/S; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Novo Nordisk A/S is seeking a Principal Specialist, PV Process Excellence in Bangalore. You will strengthen governance, translate regulatory requirements into compliant, scalable ways of working and support patient safety systems across global pharmacovigilance.

The role focuses on governance, continuous improvement, regulatory intelligence, and training, with collaboration across GPS, R&D and regional offices to keep processes mature and inspection-ready.

Qualifications

• Bachelor's degree in life sciences or related field.
• 5–10 years' pharmacovigilance experience.
• Experience in pharmacovigilance operations, quality systems, governance or QPPV Office functions.
• Understanding of worldwide pharmacovigilance regulation and translating requirements into pragmatic execution.
• Regulatory intelligence, process governance and training experience is a plus.

Responsibilities

• Lead governance and continuous improvement across PV Process Excellence areas.
• Facilitate regulatory intelligence and governance boards, ensuring rigour and efficiency.
• Assess emerging pharmacovigilance regulations and translate into organizational requirements.
• Oversee regulatory changes impacting the pharmacovigilance system; manage change impact.
• Support GPS training governance framework and curricula.
• Own procedural documentation for the PV Process Excellence team.

Skills

PV operations

Governance

Quality systems

Regulatory intelligence

Strategic planning

Stakeholder mgmt

English fluency

Education

Bachelor's degree in life sciences

Job description

Category: Reg Affairs & Safety Pharmacovigilance

Location: Bangalore, Karnataka, IN

Principal Specialist, PV Proc Excellence

Your impact begins here

As Principal Specialist, PV Process Excellence, you will strengthen the governance and continuous improvement of Novo Nordisk's global pharmacovigilance processes. You will translate emerging regulatory requirements into sustainable, compliant and inspection-ready ways of working, and help keep our patient safety system effective at scale. Your work supports the integrity of the system that protects people who rely on our medicines every day.

What you'll bring

We are looking for a structured, detail-oriented professional who thrives in a complex, global environment and is motivated by continuous improvement. To succeed, you bring:

• A Bachelor's degree in life sciences or a related field, combined with 5–10 years' relevant pharmacovigilance experience.
• Significant experience within pharmacovigilance operations, quality systems, governance, compliance or QPPV Office functions.
• A strong understanding of worldwide pharmacovigilance regulation and the ability to translate requirements into pragmatic, high-quality execution.
• Experience in pharmacovigilance regulatory intelligence, process governance and training will be a an added advantage
• Demonstrated ability to provide strategic planning, governance and oversight across multiple large-scale, com-plex assignments.
• Strong communication and stakeholder-management skills.
• A team-oriented mindset with flexibility, change readiness and a drive to simplify while maintaining compliance.
• Fluency in English, both written and spoken.

What you'll do

You will drive strategic governance and continuous improvement across one or more Process Excellence areas, working alongside content owners and functional stake-holders to keep processes mature and inspection-ready. Day to day, you will:

• Facilitate the regulatory intelligence and process governance boards, deputising for the Chair when required, and ensure the frameworks run with operational rigour and efficiency.
• Drive systematic surveillance and assessment of emerging pharmacovigilance regulations, guidelines and best practices, and translate them into actionable organisational requirements.
• Maintain oversight of global and local regulatory changes impacting the pharmacovigilance system, and manage the impact of process changes across it.
• Advance the maturity and inspection readiness of pharmacovigilance processes, standards and procedures, harmonising global procedures with functional stake-holders.
• Support the global training governance framework, shaping GPS training curricula, role-based learning, effec-tiveness measurement and compliance monitoring.
• Take primary ownership of specific procedural documentation for the PV Process Excellence team.

Who you'll work with

You will join the QPPV Office team within Global Patient Safety (GPS) in Research & Development – the team re-sponsible for the integrity, quality and compliance of our global pharmacovigilance system. In R&D, colleagues explore bold scientific ideas and advance them into clinical testing, combining curiosity, data and technology to meet future patient needs.
You will work closely with the Director, PV Process Excellence, the EU QPPV and Deputy QPPVs, and Global Patient Safety leadership. Your wider network spans GPS departments, our Global Business Services centre in Bangalore, Novo Nordisk affiliates, R&D, health authorities and contractual partners across the globe – bringing the right expertise together to keep the system compliant and moving forward.

What you can expect here

You will work in a global environment where your expertise shapes how our pharmacovigilance system operates and where you are trusted to take ownership and speak up. The role offers the chance to build new skills through cross-functional collaboration, grow alongside experienced colleagues, and be supported to perform at your best while contributing to a shared standard of quality and compliance.

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