(Associate) Manager Pharmacovigilance (all genders)

AbbVie; Wiesbaden; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

AbbVie sucht einen (Associate) Pharmacovigilance Manager in Wiesbaden, um die Sicherheit von Arzneimitteln zu gewährleisten und die PV-Prozesse zu optimieren. In einem dynamischen Team werden Sie an der Schnittstelle zwischen verschiedenen Abteilungen arbeiten und zur Verbesserung der Patientensicherheit beitragen. Wir bieten ein vielfältiges Arbeitsumfeld, wettbewerbsfähige Gehälter und internationale Karrieremöglichkeiten.

Leistungen

Vielfältige Arbeitsumgebung

Wettbewerbsfähiges Gehalt

Flexible Arbeitsmodelle

Gesundheits- und Wellnessprogramme

Internationale Karrieremöglichkeiten

Qualifikationen

• Mindestens 3 Jahre Erfahrung in der Pharmakovigilanz.
• Umfassendes Wissen über PV-Systeme und medizinische Terminologie.
• Fließend in Englisch und Deutsch.

Aufgaben

• Unterstützung des PV-Leiters bei lokalen PV-Aktivitäten.
• Überwachung der PV-Systemleistung und Einhaltung der Vorschriften.
• Durchführung von Schulungen für neue Mitarbeiter.

Kenntnisse

Qualitätsbewusstsein

Globale Perspektive

Starke Kommunikationsfähigkeiten

Analytische Fähigkeiten

Prozess- und Betriebsexzellenz

Ausbildung

Fortgeschrittenes Lebenswissenschaftsabschluss (z.B. M.S., M.B.A., PharmD.)

Jobbeschreibung

Unternehmensbeschreibung

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.

Stellenbeschreibung

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It's a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to address some of tomorrow's unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities to develop and enhance your skills? You’ve come to the right place!

As part of the Regional Safety Operations team at the Wiesbaden site, you will work with talented people and experienced management experts to maintain a high-functioning PV system, enhance our drug safety processes, and protect patient well-being.

Together, we break through – as (Associate) Pharmacovigilance Manager

As an (Associate) Pharmacovigilance Manager, you will support the Pharmacovigilance Lead (PV Lead) and the Affiliate Safety Representative (ASR) in all aspects of your role and responsibilities, ensuring that local PV activities and requirements align with AbbVie processes and procedures, the Code of Business Conduct, and local laws.

Make your mark:

Your main responsibilities will include:

• Safety Science:
  • Support the ASR in establishing a solid local safety and PV strategy, including proactive PV contributions to ensure successful product/indication launches at the affiliate.
  • Build strong partnerships and collaborate with stakeholders and other functions such as Regulatory Affairs, Medical Affairs, and Brand Teams.
  • Maintain awareness of safety-related product inquiries/issues from external stakeholders/vendors, working with Medical Affairs, Regulatory Affairs, Area Product Leads, and the PSEQ Product Safety Team as needed.
  • Engage internal local stakeholders regarding safety monitoring results, effectively communicating relevant safety information impacting business strategies.
  • Monitor Local Safety Information and escalate findings to the Affiliate Medical Director and PSEQ for evaluation promptly.
• PV System Oversight:
  • Collaborate with Pharmacovigilance and Patient Safety, Epidemiology, R&D Quality Assurance (PSEQ) regional teams, and local PV teams to support the PV Lead and the ASR in overseeing all aspects of PV system performance and compliance with local regulations, internal standards, and timelines.
• PV Training:
  • Assist the ASR and PSEQ Regional PV Teams in ensuring training compliance with corporate procedures and local PV requirements, maintaining the local PV Training matrix, and developing additional PV training as needed (e.g., Risk Minimization Trainings).
  • Conduct training sessions during AbbVie's onboarding process, ensuring proper documentation.
• Medical Research Support:
  • Ensure PV requirements are implemented in observational studies, Post-Marketing Observational Studies (PMOS), and Investigator-Initiated Studies (IIS).
• Quality Management:
  • Support ASR and PSEQ regional teams to establish and maintain quality systems aligned with corporate and local requirements.
  • Contribute to the creation and update of local PV guidelines.
  • Manage CAPAs.
  • Support the development and testing of risk-based Business Continuity plans for PV processes.
• Audits and Inspection Management:
  • Assist in managing internal PV audits of affiliate service providers/third parties and regulatory authority PV inspections, including CAPA development and tracking.
• Additional Responsibilities:
  • Coordinate the local PV mailbox.
  • Support PV review and approval of promotional and non-promotional materials.

Qualifikationen

Skills

• Quality mindset
• Global perspective
• Strong communication and influencing skills
• Excellent organizational and analytical abilities with attention to detail
• Ability to identify, manage, and escalate issues promptly
• Process and operational excellence

Education/Knowledge

• Academic or professional scientific background
• Advanced life sciences degree (e.g., M.S., M.B.A., PharmD.) preferred
• Fluent in English and German (reading, writing, speaking)

Experience

• Minimum 3 years of PV experience
• Broad PV systems knowledge, including case processing, understanding medical terminology, and causal relationships; experience in Signal Management, RMP, DSUR, PSUR is a plus
• Thorough knowledge of local/regional/area legislation and guidance (clinical trials, pre- and post-marketing)
• Experience in Safety Science strategies and execution is desirable
• Change management experience
• Knowledge of root cause analysis principles

What we offer you:

• A diverse work environment with impactful opportunities
• An open corporate culture
• Competitive salary
• Comprehensive onboarding including a mentor
• Flexible work models for work-life balance
• Health and wellness programs
• Company social benefits
• International career opportunities
• Development programs
• Strong international network

Zusätzliche Informationen

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich, mit Integrität zu arbeiten, Innovationen voranzutreiben, Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgebern, Veteranen und Menschen mit Behinderungen.