Principal Specialist - Pharmacovigilance Process Excellence

Novo Nordisk India Pvt Ltd; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Novo Nordisk India Pvt Ltd is seeking a Senior Principal Specialist in PV Process Excellence to strengthen governance and continuous improvement of our global pharmacovigilance processes in Bangalore.

You will translate regulatory requirements into compliant, inspection-ready ways of working and help keep our patient safety system effective at scale. This role collaborates with GPS and QPPV Office, demanding strong communication and stakeholder management.

Qualifications

• Bachelor's degree in life sciences or related field with 5–10 years' pharmacovigilance experience.
• Experience in pharmacovigilance operations, quality systems, governance or QPPV Office.
• Understanding of worldwide pharmacovigilance regulation and translating requirements into execution.
• Experience in regulatory intelligence, process governance and training is an advantage.
• Ability to provide strategic planning, governance and oversight across large-scale assignments.
• Strong communication and stakeholder-management skills.
• Team-oriented mindset with flexibility and change readiness.
• Fluency in English, both written and spoken.

Responsibilities

• Drive strategic governance and continuous improvement across one or more Process Excellence areas.
• Facilitate regulatory intelligence and governance boards with operational rigour.
• Surveil emerging pharmacovigilance regulations and translate into organisational requirements.
• Maintain oversight of global/local regulatory changes affecting the pharmacovigilance system.
• Advance maturity and inspection readiness of PV processes, harmonising procedures.
• Support GPS training governance, shaping curricula and compliance monitoring.
• Own specific procedural documentation for the PV Process Excellence team.

Skills

PV operations

Quality systems

Governance

Regulatory intelligence

Process governance

Training

Strategic planning

Stakeholder management

English fluency

Education

Bachelor's degree in life sciences

Job description

Principal Specialist, PV Process Excellence Team Global Patient Safety Location: Bangalore, Novo Nordisk Global Business Services (GBS), India

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

• 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.

Experience Level Senior Level