Pharmacovigilance Lead, Region Apac

Pharmacovigilance Lead, Region APAC

**Category**:Reg Affairs & Safety Pharmacovigilance

**Location**:Singapore, Singapore, SG
- Headquartered in Singapore, we are re-establishing Region APAC with the clear ambition to triple patient reach and deliver on the potential of our 16 markets: 5 elevated affiliates with Oceania, India, Korea, Thailand, Indonesia, as well as with Business Area ‘BASEA’ responsible for these 11 countries: Bangladesh, Brunei, Cambodia, Laos, Malaysia, Maldives, Myanmar, Philippines, Singapore, Sri Lanka and Vietnam. Our 3500 colleagues in APAC will pursue the opportunity to bring our innovative treatments to even more patients and contribute to IO’s ambition to Improve Health at Scale.

**About the department**
You will be part of the Clinical and Regulatory function, a newly created and focused area established to reflect our significant clinical footprint and vital role in supporting the company's pipeline. This strategic move underscores our commitment to advancing clinical development and ensuring regulatory compliance, which are essential to our success and growth.
With a dedicated focus on clinical and regulatory excellence, we aim to further accelerate the introduction of our innovative treatments to patients in the APAC region. The atmosphere is dynamic, collaborative, and purpose-driven, with a shared mission to make a meaningful difference in patients' lives.

**The position**
As a Pharmacovigilance Lead, you will be responsible for leading and overseeing the overall pharmacovigilance processes and activities in the Asia Pacific (APAC) region to ensure internal and external PV compliance, with the ultimate objective of safeguarding patient safety.
- Key responsibilities include, but are not limited to:

- Create and Lead the APAC PV Leadership team, including affiliate Qualified Person of Pharmacovigilance (QPPV) and safety responsible persons. Coordinate PV compliance activities across the region: Individual Case Safety Report (ICSR), clinical safety reports, PV deviations, audits, inspection trends, and raise awareness.
- Establish and maintain strong Patient Safety awareness and a robust PV governance system, ensuring PV roles, processes, and responsibilities are anchored in affiliates aligned with local and international requirements.
- Monitor local PV regulations systematically in affiliates and ensure timely implementation of new or changed PV requirements with proper impact assessment as well as Provide Global Patient Safety (GPS) timely feedback on major PV requirement changes or challenges and support collaboration.
- Implement a proactive compliance approach through regular review and trending of PV deviations, ICSR compliance, audit and inspection findings, and PV resource issues. Also, conduct face-to-face mock PV audits at APAC affiliates to verify compliance and determine challenges and mitigation strategies.

**Qualifications**
- University degree in Pharmacy, Medicine, or related scientific educational background.
- Over 7 years of experience in Pharmacovigilance, with solid experience working in international teams and demonstrated leadership.
- Strong leadership and business acumen, showing agility and fast solution orientation, with strong stakeholder management, cross-functional collaboration and communication with impact.
- Experience leading teams without direct reporting lines, able to create and drive strategy.
- Solution-oriented, responsible, detail-focused, proactive, able to navigate diverse setups easily, self-motivated, with an independent working style; advanced English language skills.

**Working at Novo Nordisk**
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**
- 29 June 2025

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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