Senior Portfolio Owner Pharmacovigilance (m/f/d)

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.

Your profile

What sets you apart:

Academic Qualification & Professional Experience Master’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:

Corporate culture & internationality

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.

Contact

We look forward to receiving your detailed application! Please only use the ‘ Apply now! ’ function to submit your application.

Your contact person:

Nadine Gustke

Talent Acquisition Partner

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung

Veröffentlicht am 02. Nov. 2026