Senior Portfolio Owner Pharmacovigilance (m/f/d)
We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market.
This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE’. 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.
What makes your day with us special:
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 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. Working time account with compensatory time off and 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.
We look forward to receiving your detailed application! Please only use the ‘Apply now!’ function to submit your application.
Your contact person:
1. Nadine Gustke
2. Talent Acquisition Partner
3. nadine.gustke@cheplapharm.com
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