Senior Portfolio Owner Pharmacovigilance (m/f/d)

The Task of the Senior Portfolio Owner Pharmacovigilance is to provide end-to-end ownership of al pharmacovigilance product-related activities, ensuring a strong product strategy that supports compliance, product availability and patient safety. The role acts as the central point of accountability and escalation and coordinates operations while providing disciplinary and functional leadership to the product team. By organizing and prioritizing work, fostering cross-functional alignment, and involving relevant experts when needed, the role ensures effective colaboration and high-quality outcomes across departments. Product Safety, PV & Risk Management

• Accountable for all core pharmacovigilance activities, including case processing, causality and labeledness assessment, signal detection, safety evaluation, risk mitigation, and crisis management. Ensures implementation of risk management measures and regulatory deliverables (e.g. PSURs, safety variations) in line with global GVP requirements.
• Strategic Safety & Regulatory Leadership
• Defines and drives the global product safety strategy and ensures integration of safety insights into the product lifecycle. Responsible for regulatory PV compliance, inspection readiness, and alignment with global health authority expectations. Team Leadership & Operational Governance
• Provides disciplinary and functional leadership to the PV team, including resource allocation, budgeting, task prioritization, capability development, and final decision-making responsibility. Cross-Functional & External Stakeholder Management
• Ensures strong alignment with internal stakeholders (e.g. SCM, Therapeutic Areas, Quality, Regulatory) and acts as central escalation point (SPOC). Manages relationships with external partners, vendors, and service providers to ensure quality and compliance.
• Continuous Improvement & Regulatory Intelligence
• Monitors global regulatory developments, evaluates new PV tools and processes, and drives continuous improvement of safety systems and methodologies in collaboration with medical and scientific functions.

What sets you apart:

• Academic Qualification & Professional ExperienceMaster’s degree in a scientific or related discipline combined with more than 10 years of professional and leadership experience in complex, matrixed and cross-functional organizations and more than 8 years professional experience in Pharmacovigilance.
• Leadership & Organizational Management
• Proven ability to lead teams in highly complex environments with frequently changing interfaces, ensuring effective coordination across multiple departments and stakeholder groups. Communication & Stakeholder Management
• Strong leadership and communication skills with the ability to motivate teams and build effective relationships with internal and external stakeholders in demanding, multi-level environments. Strategic & Analytical Thinking
• Ability to evaluate different solution approaches, work within partially defined frameworks, and develop robust concepts based on market practices and organizational needs. Decision-Making & Problem Solving
• Experience in handling complex and partly uncertain problem situations with medium- to long-term impact, including decision-making based on incomplete information and scenario-based assumptions.
• Autonomy & Execution Responsibility
• High degree of autonomy in adapting processes and methods to achieve operational and strategic objectives within a defined organizational scope.

What we offer you besides the job:

• A growing company with a diverse, open working environment and employees from around 40 countries. Flexible working models & work-life balance
• Individually customisable working models, including the option to work from another EU country for up to two months per year. 30 days of holiday. Individual benefits & pension provision
• Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs. Discounts & additional benefits
• Access to the corporate benefits platform with discounts at hundreds of partner companies. Further development & team culture
• Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.