Director – Safety Operations

Novo Nordisk

. Lead the Safety Operations Centre of Expertise and Submissions .

Posted 10/13/2026full-timeSøborg • DenmarkLead💰 DKK 940,800 - DKK 1,448,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance, including knowledge of international legislation and guidelines, while leading safety operations and optimizing processes for clinical and post-marketing products. Proven ability to manage teams effectively across global hubs and ensure compliance with regulatory requirements.

Highest-signal resume keywords

Pharmacovigilance ExperienceProcess OptimizationPeople LeadershipRegulatory ComplianceCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance LegislationICSR HandlingCase ProcessingAutomation ImplementationBusiness Process Knowledge

Soft Skills

Negotiation SkillsConflict ManagementStrategic MindsetInspiration SkillsCalm Issue Handling

Tools & Technologies

Safety Reporting SystemsIT Systems for Safety Operations

Certifications & Qualifications

Master’s Degree in Life Sciences

Industry Keywords

Clinical ProductsPost-Marketing ProductsGlobal Patient SafetyHealth AuthoritiesRegulatory Submission

About the role

Key responsibilities & impact

Lead the Safety Operations Centre of Expertise and Submissions
Set the future direction for the Safety Operations area
Lead daily operations through a manager and directly manage Safety Operations specialists
Establish, maintain and continuously optimise end-to-end ICSR handling for clinical and post-marketing products
Oversee case processing from affiliate intake through regulatory submission
Drive operational efficiency, simplification and automation while maintaining quality, compliance and timely reporting
Ensure safety reporting systems and processes remain current and compliant with regulatory requirements and guidelines
Influence emerging requirements for safety information handling
Build networks across headquarters, affiliates and external collaborators
Communicate new procedures and processes across the worldwide pharmacovigilance organisation
Ensure consistent onboarding and training across Safety Operations
Lead approximately 20 people and secure operational excellence across Denmark, the US and Bangalore, India
Collaborate with Global Patient Safety, project teams, Global Trial Portfolio, Enterprise IT, AI and Digital Innovation, regions, affiliates, Quality, Finance, Legal and senior management
Interact with health authorities, investigators and vendors

Requirements

What you’ll need

Master’s degree in life sciences
Extensive pharmacovigilance experience in a large-scale pharmaceutical company, including senior specialist roles
Extensive knowledge of international pharmacovigilance legislation and guidelines
Proven success optimising processes and systems
Solid knowledge of business processes and IT systems supporting safety operations
Strong people leadership experience, including leading through other leaders
Professional authority to set direction
Strong communication, negotiation and conflict-management skills
Ability to analyse and handle complex, urgent or sensitive issues calmly
Strategic mindset and ability to inspire others
Willingness to take tough decisions for the benefit of the wider organisation
Hands-on experience implementing automation in case processing or regulatory submissions is useful but not essential
Experience working across global hubs or influencing new regulatory requirements in external working groups is useful but not essential

Benefits

Comp & perks

Short-term and/or long-term incentives may be included
Other employee benefits based on position level, location, functional area, and relevant market benchmarks
Opportunities to grow through cross-functional work and global collaboration
Relevant learning offerings
Inclusive recruitment process and equality of opportunity