CHEPLAPHARM Arzneimittel GmbH
Senior Portfolio Owner Quality(m/w/x)
Vollzeitmit HomeofficeSenior
Greifswald, Berlin, Binningen
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CHCHEPLAPHARM Arzneimittel GmbH
Senior Portfolio Owner Pharmacovigilance(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
End-to-end ownership of pharmacovigilance product strategy for established pharmaceutical brands. Master's degree and 8+ years in pharmacovigilance required. 30 days holiday, option to work from another EU country.
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Anforderungen
- Master’s degree in scientific or related discipline
- More than 10 years professional and leadership experience in complex, matrixed, cross-functional organizations
- More than 8 years professional experience in Pharmacovigilance
- Proven ability to lead teams in complex environments with changing interfaces
- Effective coordination across multiple departments and stakeholder groups
- Strong leadership skills
- Strong communication skills
- Ability to motivate teams
- Ability to build effective relationships with stakeholders
- Ability to evaluate solution approaches
- Work within partially defined frameworks
- Develop robust concepts based on market practices and organizational needs
- Experience handling complex problem situations
- Experience handling uncertain problem situations with medium- to long-term impact
- Decision-making based on incomplete information
- Decision-making based on scenario-based assumptions
- High degree of autonomy in adapting processes and methods
- Achieve operational and strategic objectives within defined scope
Aufgaben
- Provide end-to-end ownership of pharmacovigilance product-related activities
- Ensure strong product strategy for compliance, availability, and patient safety
- Act as central point of accountability and escalation
- Coordinate operations and provide leadership to the product team
- Organize and prioritize work
- Foster cross-functional alignment
- Involve relevant experts when needed
- Ensure effective collaboration and high-quality outcomes
- Manage core pharmacovigilance activities
- Process cases, assess causality and labeledness
- Detect signals and evaluate safety
- Mitigate risks and manage crises
- Implement risk management measures
- Deliver regulatory requirements (e.g., PSURs, safety variations)
- Align with global GVP requirements
- Define and drive global product safety strategy
- Integrate safety insights into product lifecycle
- Ensure regulatory PV compliance
- Prepare for inspections
- Align with global health authority expectations
- Provide disciplinary and functional leadership to PV team
- Allocate resources and manage budget
- Prioritize tasks and develop capabilities
- Make final decisions
- Align with internal stakeholders (e.g., SCM, Therapeutic Areas, Quality, Regulatory)
- Act as central escalation point (SPOC)
- Manage external partners, vendors, and service providers
- Ensure quality and compliance
- Monitor global regulatory developments
- Evaluate new PV tools and processes
- Drive continuous improvement of safety systems and methodologies
- Collaborate with medical and scientific functions
Berufserfahrung
10 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Individually customisable working models
Workation & Sabbatical
- Option to work from another EU country (up to 2 months/year)
Mehr Urlaubstage
- 30 days of holiday
Sonstige Zulagen
- Flexible benefits budget
- Subsidies for meal costs
Betriebliche Altersvorsorge
- Increased company pension provision
Gesundheits- & Fitnessangebote
- Fitness and health offers
Öffi Tickets
- Subsidies for travel costs
Mitarbeiterrabatte
- Corporate benefits platform access
- Discounts at partner companies
Weiterbildungsangebote
- Internal and external training courses
Team Events & Ausflüge
- Company events
- Team events
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens CHEPLAPHARM Arzneimittel GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei CHEPLAPHARM Arzneimittel GmbHÜber das Unternehmen
CH
PharmaceuticalsGreifswald
Das Unternehmen ist ein globales und wachsendes Specialty Pharmaunternehmen mit einem außergewöhnlichen, nachhaltigen Geschäftsmodell.
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