DACH & EU Mid-Size Cluster Lead (m/f/x)

vor 2 Wochen

Marburg HE, Marburg, Deutschland CSL Behring Vollzeit

For our Global Safety and Pharmacovigilance department, we are looking for a

DACH & EU Mid-Size Cluster Lead (m/f/x)

R-248154

Fulltime / permanent/ non-tariff

The DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety Officer(s) within the designated cluster. This position provides expert input on pharmacovigilance-related matters and develops strategy for the assigned cluster, ensuring PV processes are completed seamlessly in support of the organization’s long-term vision and goals. Acts as the primary point of contact for Safety Officers (SOs) in the respective cluster and work closely with the Regional Head of Europe, IPV to manage regional PV activities, operational issues & risks, projects and ultimately optimize the cohesiveness of the region. This role will maintain relationships with General Managers of this cluster.

The Opportunity

  • Provides strategic leadership and guidance to Pharmacovigilance (PV) team members, as well as the wider organisation, to ensure the delivery PV activities in alignment with the requisite quality and compliance standards.
  • Directly manages and develops the PV team in the assigned region, setting clear performance expectations and providing regular feedback. Fosters a collaborative and high-performance culture within the team, encouraging innovation and continuous improvement. Conducts performance reviews, identifies development needs, and implements development plans to enhance team capabilities.
  • Ensure adequate resourcing and succession planning within the PV team to meet current and future business needs.
  • Support Regional Head of Europe in development and implementation of a comprehensive PV strategy for the region, ensuring alignment with local and global regulatory requirements and corporate objectives. Ensures that the license to operate is maintained. Acts as a primary point of contact for all PV-related matters in their region, and timely communication and escalation of PV-relevant issues as per established global processes.
  • Accountable for consistent implementation of GVP compliant processes, global standards and regulatory requirements in collaboration with interfacing functions within the cluster.
  • Oversees the assessment, communication, and implementation of new or updated PV requirements in the region. Provides strategic advice to management and directs and reviews updates to controlled documents and platforms to align with evolving regulations
  • Leverages a diverse and robust set of sources including but not limited to regulatory intelligence, continuous improvement initiatives, key performance indicators (KPIs) as well as audit/inspection findings, to direct enhancements to local PV systems. Oversees SO compliance against available KPIs and follows up in case of non-compliance. Supports SOs with compliance improvement activities and escalates issues and trends to key stakeholders in IPV as needed.
  • Oversee/support IPV projects and improvement initiatives, as delegated by the Head of Europe, International Pharmacovigilance.
  • Establishes good working relationships with GSPV, Global Regulatory Affairs (GRA), regional counterparts and local stakeholders, such as Local Quality Officer (e.g., for PTCs), Marketing and Medical Affairs (e.g., for ODCSs) etc. Partakes in internal meetings regarding product safety, as needed.
  • Responsible for effective stakeholder management and communication with key departments (ComOps, GRA, R&DQA etc…). Establishes and maintains strong partnerships with CSL’s enterprise commercial functions to enhance the performance of local PV activities, assess impact on resource, budget and managed services
  • Participates in local/regional Commercial Operations Leadership Team meetings as required and provides input to strategic planning discussions as needed, ensuring alignment of PV activities with broader organizational objectives.
  • Serves as PV Subject Matter Expert for local PV inspections by Regulatory Authorities in collaboration with LSOs, CSL QPPV, GSPV IPV, PVRQA, and relevant functions. Oversees and provides support to SOs in the preparation of audit / inspection, and in compliment to the IPV Audit, Inpsection & Performance Optimisation (AIPO) strategy. Provides strategy and input on close-out activities including the development of CAPA plans and close out of action items. Ensures all commitments in the region are completed in a timely manner.
  • Serves as the SO in resident/designated country, as required.

Your Skills and Experience

  • Bachelor’s degree / Diploma (e.g. in the biological, nursing, healthcare or pharmaceutical sciences, quality or economics) or equivalent
  • 9+ years experience in the Pharmaceutical or Biotech industry, in accordance with applicable local pharmacovigilance legislation
  • Demonstrated ability to lead diverse teams and deliver results.
  • Knowlege of international standards and regulatory requirements/regulations related to pharmacovigilance
  • Excellent written and verbal communication skills in English required
  • Fluency in one or more languages of the region would be a plus

  • Travel Requirements: domestic and international, up to 15% of the year

What we offer

  • Excellent income potential and extended benefits
  • Two additional leave days for your personal wellbeing
  • Family services such as psychological support, legal advice, family care services and more for you and your direct family
  • Hybrid working models

For more information, please check out our global benefits below

We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring

  • Safety Systems Project Lead

    vor 4 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aSafety Systems Project Lead (m/f/x)R-246740Fulltime / permanent/ non-tariffAs Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance...

  • Sourcing Specialist

    Vor 7 Tagen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    For our procurement department in Marburg, we are looking for aSourcing Specialist (m/f/x)R-248534Fulltime / permanent / tariffInternal job title: Sourcing Specialist 2The OpportunityUnder general supervision, supports sourcing and procurement for assigned area/category/site/special projects.Reviews projects to understand internal client needs, savings...

  • Senior Biostatistician

    vor 4 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    For our Research department in Marburg, we are looking for aSenior Biostatistician (m/f/x)R-247809Fulltime / permanent / tariff The OpportunityWe have an opportunity available for a Senior Research Statistician to join our Research Data Science team. You will provide scientific expertise in the area of biostatistics for a broad array of applications in...

  • HR Site Lead Marburg

    vor 1 Monat

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Human Resources in Marburg suchen wir aktuell eine/nHR Site Lead Marburg (m/w/x)R-243264Vollzeit / unbefristet / ATAls HR Site Lead verantworten Sie die lokale Umsetzung Globaler HR-Strategien und Initiativen am Standort. Sie treiben die HR-Agenda, Personalprozesse und Programme und in Einklang mit den HR- und Unternehmensstrategien...

  • Senior Employee Relations Manager/in

    vor 2 Monaten

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Human Resources suchen wir aktuell eine/nSenior Employee Relations Manager/in (m/w/x) R-235152Vollzeit / unbefristet / ATSie fungieren als strategische/r Partner/in für das CSL-Management und agieren als Mentor/in innerhalb des ER-Teams. Als solche/r arbeiten Sie eng mit HR-Business Partnern, Managern, Mitarbeitenden, Rechts- und...

  • Laborant/in (m/w/x) - Quality Control

    vor 3 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Quality Control (Sterilitätslabor) in Marburg suchen wir aktuell einenLaborant/in 1 Quality Control (m/w/x)R-247853Vollzeit / unbefristetAufgabeZusammenstellen und Bewerten von Ergebnissen gemäß den Prüfungsanweisungen und verschiedener, auch komplexer Routineanalysen im LaborAufbau von Geräten gemäß vorhandenen Beispielen und...

  • GMP-Koordinator (m/w/x)

    vor 4 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Value Stream – Basisfraktionierung in Marburg suchen wir aktuell eine/nGMP-Koordinator/in (m/w/x)R-246518Vollzeit / unbefristet / TarifFür den größten Standort von CSL Behring suchen wir aktuell nach Mitarbeitenden in unseren Produktionsabteilungen. Diese bestehen aus Herstellung, Abfüllung, visueller Kontrolle und Verpackung. Im Bereich...

  • Tax Specialist

    vor 3 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Finance in Marburg suchen wir aktuell eine/nTax Specialist (m/w/x)Vollzeit / unbefristet / Tarif E11KInterner Titel: Tax Specialist Die Tätigkeiten umfassen die Erstellung und Prüfung von Steuererklärungen, Steuerbilanzen und Bescheiden für deutsche und ausländische Gesellschaften, einschließlich der Vorbereitung von Einsprüchen...

  • Sachbearbeiter/in Data

    vor 3 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für die Abteilung M2U Operational Service Marburg, Bereich Data- & Support in Marburg suchen wir aktuell eine/nSachbearbeiter/in Data & Support (m/w/x)R-247859Vollzeit / unbefristet / TarifAufgabenAnlegen und Pflegen von Stammdaten (z.B. Produktionsanlagen und -nebenanlagen, Equipment, Stückliste und Klassifizierung sowie Wartungsplanung) aus genehmigten...

  • Technische/r Assistent/in

    vor 1 Monat

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Quality Control in Marburg suchen wir aktuell eine/nTechnische/r Assistent/in QC (m/w/x)R-247054Vollzeit / befristet 2 JahreAufgabenVorbereiten, Durchführen, Dokumentieren und Auswerten auch komplexer Analysen innerhalb eines definierten Einsatzbereiches im Labor nach detallierter Vorgabe, z.B. Keimzahlbestimmungen,...

  • Scientist - In vivo Pharmacology (m/w/x)

    vor 2 Monaten

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    For our In vivo Pharmacology division, we are looking for aScientist - In vivo Pharmacology (m/f/x)R-245681Fulltime / fixed-term, 1 year / tariff The OpportunityAs scientific and technical expert for in vivo studies across several therapeutic areas but mainly focused on Hematology, the incumbent is responsible for conducting and managing research activities...

  • MES-Koordinator (m/w/x)

    vor 2 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Value Stream – Basisfraktionierung in Marburg suchen wir aktuell eine/nMES-Koordinator (m/w/x)R-247782Vollzeit / unbefristet / TarifInterner Titel: MES-Koordinator 2Für den größten Standort von CSL Behring suchen wir aktuell nach Mitarbeitenden in unseren Produktionsabteilungen. Diese bestehen aus Herstellung, Abfüllung, visueller...

  • Personalsachbearbeiter Shared Services

    vor 4 Monaten

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Personalwesen in Marburg suchen wir aktuell eine/nPersonalsachbearbeiter Shared Services (m/w/x)R-242221Vollzeit / unbefristet / TarifInterner Titel: HR Operations Advisor (Tier 1)In dieser abwechslungsreichen Position berichten Sie an den Senior Manager aus dem Bereich Employee Experience and Services und sind zusammen mit Ihren...

  • CPG Senior Financial Analyst

    vor 3 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Finance CSL Plasma in Marburg suchen wir aktuell eine/nCPG Senior Financial Analyst / Controller Plasma: in (m/w/x)R-242996Vollzeit / unbefristet / Tarif E12KInterner Titel: CPG Senior Financial Analyst / Controller PlasmaInternes Ausschreibungsende: 23.10.2024Die Stelle berichtet an den Director Finance & Controlling CSL PlasmaDie...

  • Laborant/in - Quality Control

    vor 3 Wochen

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Quality Control in Marburg suchen wir aktuell einenLaborant/in - Quality Control (m/w/x)R-247852Vollzeit / unbefristetAufgabeZusammenstellen und Bewerten von Ergebnissen gemäß den Prüfungsanweisungen und verschiedener, auch komplexer Routineanalysen im LaborAufbau von Geräten gemäß vorhandenen Beispielen und schriftlichen...

  • Quality on the Floor Person

    vor 5 Monaten

    Marburg, HE, 35037, Marburg, Deutschland CSL Behring Vollzeit

    Für unseren Bereich Quality Assurance in Marburg suchen wir aktuell eine/nQuality on the Floor Person (m/w/x)R-238283Vollzeit /befristet / Tarif 7Interner Titel: Quality on the Floor Person BulkInternes Ausschreibungsende: 06.08.2024Die Aufgaben umfassen die Überprüfung kritischer Prozessschritte und Dokumentationen gemäß GMP-Richtlinien und SOPs, um...

  • Dach & Eu Mid-size Cluster Lead (M/F/x)

    vor 2 Wochen

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    For our **Global Safety and Pharmacovigilance**department, we are looking for a **DACH & EU Mid-Size Cluster Lead (M/F/x)**: R-248154 Fulltime / permanent/ non-tariff The DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety Officer(s)...

  • DACH & EU Mid-Size Cluster Lead (m/f/x)

    vor 2 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for a DACH & EU Mid-Size Cluster Lead (m/f/x) R-248154 Fulltime / permanent/ non-tariff The DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety Officer(s) within the...

  • DACH & EU Mid-Size Cluster Lead (m/f/x)

    vor 2 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aDACH & EU Mid-Size Cluster Lead (m/f/x)R-248154Fulltime / permanent/ non-tariffThe DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety Officer(s) within the...

  • DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)

    vor 1 Woche

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aDACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)R-248154Fulltime / permanent/ non-tariffThe DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety...

  • DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)

    Vor 5 Tagen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aDACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)R-248154Fulltime / permanent/ non-tariffThe DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety...

  • DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)

    vor 1 Woche

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for a DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x) R-248154 Fulltime / permanent/ non-tariff The DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage...

  • DACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)

    Vor 7 Tagen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aDACH & EU Mid-Size Affiliate Pharmacovigilance Cluster Lead (m/f/x)R-248154Fulltime / permanent/ non-tariffThe DACH & EU Mid-Size Cluster Lead is a core member of the EU Regional, International Pharmacovigilance (IPV) team, GSPV. The purpose of the role is to lead and manage Safety...

  • Global Pharmacovigilance Cluster Lead

    vor 2 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Job DescriptionWe are seeking a highly skilled Global Pharmacovigilance Cluster Lead to join our team at CSL Behring.About the RoleThis is an exceptional opportunity for a seasoned professional to lead and manage Safety Officers within a designated cluster, providing expert input on pharmacovigilance-related matters and developing strategies to ensure...

  • Senior Pharmacovigilance Cluster Lead

    vor 1 Woche

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Job SummaryCandidates with expertise in pharmacovigilance are sought after to fill the position of Senior Pharmacovigilance Cluster Lead at CSL Behring. This role offers an excellent opportunity for professionals to demonstrate their leadership skills, strategic thinking, and technical knowledge in pharmacovigilance.About the RoleThe successful candidate...

  • HR Site Lead Marburg

    vor 3 Monaten

    Marburg, Deutschland CSL Behring GmbH Vollzeit

    CSL Behring ist ein weltweit führendes Unternehmen im Bereich Biotherapeutika, das sich dem Versprechen verschrieben hat, Leben zu retten. Wir konzen­trieren uns darauf, die Bedürf­nisse der Patienten durch den Einsatz modernster Technologien zu erfüllen, und entwickeln und liefern inno­vative Therapien zur Behandlung von Gerinnungs­störungen,...

  • Safety Systems Project Lead

    vor 4 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for a Safety Systems Project Lead (m/f/x) R-246740 Fulltime / permanent/ non-tariff As Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in...

  • Safety Systems Project Lead

    vor 4 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aSafety Systems Project Lead (m/f/x)R-246740Fulltime / permanent/ non-tariffAs Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance...

  • Safety Systems Project Lead

    Vor 5 Tagen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aSafety Systems Project Lead (m/f/x)R-246740Fulltime / permanent/ non-tariffAs Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance...

  • Safety Systems Project Lead

    Vor 7 Tagen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Global Safety and Pharmacovigilance department, we are looking for aSafety Systems Project Lead (m/f/x)R-246740Fulltime / permanent/ non-tariffAs Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance...

  • Product Manager

    vor 6 Monaten

    Hattersheim am Main, HE, 65795, Main-Taunus-Kreis, Deutschland CSL Behring Vollzeit

    To strengthen our Business Unit Hemophilia & HAE, we are currently recruiting for a Product Manager (m/f/x) - Hemophilia(Fulltime / permanent / Location: Hattersheim)The Opportunity We are looking to enhance our Hemophilia & HAE Business Unit with a dedicated Product Manager. This full-time, permanent position based in Hattersheim involves managing the...

  • Safety Systems Project Lead

    vor 1 Monat

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    For our **Global Safety and Pharmacovigilance **department, we are looking for a **Safety Systems Project Lead (M/F/x)**: **R-246740**: Fulltime / permanent/ non-tariff As Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality...

  • Head Operational Services

    vor 3 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Value Stream Base Fractionation department, we are looking for aHead of Operational Services (m/f/x) -R-247780Fulltime / permanent / Non-tariffThe main responsibility of the role is to drive and ensure the compliance (deviation management, Right first Time (RFT), GMP compliance, SOPs, training, change control, BRR, detailed scheduling, documentation,...

  • Head Operational Services

    vor 3 Wochen

    Marburg, Deutschland CSL Behring Vollzeit

    For our Value Stream Base Fractionation department, we are looking for a Head of Operational Services (m/f/x) - R-247780 Fulltime / permanent / Non-tariff The main responsibility of the role is to drive and ensure the compliance (deviation management, Right first Time (RFT), GMP compliance, SOPs, training, change control, BRR, detailed scheduling,...

  • HR Site Lead Marburg

    vor 2 Monaten

    Marburg, Deutschland CSL Behring GmbH Vollzeit

    Über CSL Behring CSL Behring ist ein weltweit führendes Unternehmen im Bereich Biotherapeutika, das sich dem Versprechen verschrieben hat, Leben zu retten. Wir konzen­trieren uns darauf, die Bedürf­nisse der Patienten durch den Einsatz modernster Technologien zu erfüllen, und entwickeln und liefern inno­vative Therapien zur Behandlung von...

  • Sourcing Specialist

    Vor 7 Tagen

    Marburg, Deutschland CSL Behring Vollzeit

    For our procurement department in Marburg, we are looking for aSourcing Specialist (m/f/x)R-248534Fulltime / permanent / tariffInternal job title: Sourcing Specialist 2The OpportunityUnder general supervision, supports sourcing and procurement for assigned area/category/site/special projects.Reviews projects to understand internal client needs, savings...