Regional Pharmacovigilance Director

Novo; Søborg; In loco; DKK 941.000 - 1.449.000; Tempo pieno

Descrizione del lavoro

Novo Nordisk A/S in Søborg, Denmark, seeks a Regional Pharmacovigilance Director to lead PV governance across Region Emerging Markets, ensuring patient safety and regulatory compliance.

You will shape PV strategy, oversee affiliate PV activities, and manage third-party safety partners while collaborating with GPS, Medical, Regulatory Affairs, and Quality to translate priorities into sustainable regional capabilities.

Competenze

• Minimum 7 years’ relevant experience in Pharmacovigilance (PV).
• Demonstrated experience conducting and/or leading PV activities at a regional level.
• Extensive knowledge of international PV legislation, including GVP.
• Ability to lead, influence and build alignment across teams without direct reporting lines.
• Strong strategic and business acumen, with translating priorities into direction and execution.
• Excellent stakeholder management and influencing skills in a multicultural matrix.
• Agile, proactive, and detail-oriented with sound judgement and accountability.
• Self-motivated and able to work independently across diverse organisational and cultural settings.
• Fluency in English (written and spoken).
• Experience with PV requirements in diverse customer engagement initiatives (PV pilot programs, patient support initiatives) would be useful.

Mansioni

• Lead PV strategy and governance for the region and oversee PV activities across affiliates to ensure compliance and patient safety.
• Oversee the design and optimisation of the regional PV operating model and resourcing strategy.
• Maintain regional oversight of PV compliance and performance through risk-based monitoring and trend analysis.
• Govern third parties and support inspection readiness, including governance and CAPAs.
• Engage with regional leadership and cross-functional teams to promote robust PV practices and scalable improvements.
• Represent the region in global governance forums and facilitate regional adoption of global processes.

Conoscenze

English fluency

Formazione

Bachelor’s degree, or Master’s/PhD in life sciences/pharma

Descrizione del lavoro

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Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

Regional Pharmacovigilance Director

Your impact begins here

As Regional Pharmacovigilance Director, you will lead pharmacovigilance (PV) governance and oversight across Region Emerging Markets, with patient safety at the heart of everything you do. You will drive operational excellence and compliance, build strong partnerships and strengthen regional capabilities. Working with Global Patient Safety and regional and affiliate leadership, you will turn regional PV priorities into action and deliver meaningful impact for patients.

What you’ll bring

We are looking for a strategic, collaborative leader who thrives in a complex, international environment. You inspire alignment, drive results through influence and foster a culture of quality, compliance and patient safety across a diverse regional community.

• A Bachelor’s degree, or a Master’s/PhD, in life sciences and/or pharmaceutical industry, combined with a minimum of 7 years’ relevant experience in Pharmacovigilance.
• Demonstrated experience conducting and/or leading PV activities at a regional level.
• Extensive knowledge of international PV legislation, including GVP.
• Demonstrated ability to lead, influence and build alignment across teams without direct reporting lines.
• Strong strategic and business acumen, with the ability to translate priorities into clear direction and drive execution.
• Excellent stakeholder management and influencing skills, with the ability to communicate with impact in a complex, multicultural matrix environment.
• Agile, proactive and focused on practical ways forward, with sound judgement, accountability and attention to detail.
• Self‑motivated and able to work independently, navigate ambiguity and adapt effectively across diverse organisational and cultural settings.
• Fluency in English, both written and spoken.

Useful, but not essential:

• Experience working with PV requirements in diverse customer engagement initiatives, such as digital health initiatives, market research programmes and patient support programmes.

What you’ll do

You will lead PV strategy and governance for the region and oversee PV activities across affiliates, enabling robust compliance, capability and patient safety in a growing business environment.

More specifically, you’ll:

• Lead regional PV strategy and community: Provide leadership with PV strategy in the region, make sure key messages reach all levels of the organisation in a timely and effective way, and foster collaboration and knowledge‑sharing to promote a culture of safety and compliance.
• Oversee regional PV activities: Lead the design and continuous optimisation of the affiliate PV operating model and resourcing strategy, using risk, workload and business needs to ensure sustainable capabilities and clear accountabilities.
• Safeguard compliance and regulatory readiness: Maintain regional oversight of PV compliance and performance through risk‑based monitoring and trending of key indicators, elevate material issues and drive sustainable remediation. Implement new or revised local PV requirements through documented impact assessments and change control and keep Global Patient Safety updated on significant developments.
• Govern third parties and support inspection readiness: Provide strategic oversight of regional and affiliate PV vendors, distributors and other third parties performing PV activities, including governance, performance monitoring, issue escalation and effective Pharmacovigilance Agreements. Support audit and inspection preparation, follow up on findings and CAPAs, and share learnings across affiliates.
• Partner with the business and strengthen affiliates: Engage with regional and affiliate leadership and cross‑functional teams (e.g. Medical, Marketing, Regulatory Affairs, Quality) to promote robust PV practices. Guide affiliates in resolving complex operational and compliance challenges, identify root causes, implement scalable improvements and support training and a robust capability framework.
• Represent the region globally: Act as the primary point of contact for the region in global governance forums, bring forward regional insights, best practices and regulatory requirements, and facilitate regional adoption of global processes, systems and transformation programmes.

Who you’ll work with

You will join the PV Excellence team within Global Patient Safety (GPS) in Research & Development, the team responsible for ensuring the integrity, quality and compliance of our global PV system. In Research & Development, colleagues explore bold scientific ideas and advance them into clinical testing, combining curiosity, AI tools and human data.

You will work closely with GPS departments, our Global Business Services centre in Bangalore, Novo affiliates, R&D, health authorities and contractual partners worldwide. In the region, your partners will be affiliate and regional leadership and key stakeholders in Medical, Marketing, Regulatory Affairs and Quality.

Based in Denmark, you will bring perspectives together across markets and cultures and help teams move from regional insight to global action.

What you can expect here

You will work in an international environment where your expertise is valued and your voice is heard. You will be trusted to take ownership, supported to perform at your best, and able to grow with your colleagues on the job and through relevant learning offerings.

Salary: For this role , the Annual Base Salary rangesfrom 940,800.00 to 1,448,700.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short‑term and/or long‑term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here .

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