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    Lead Eu-Qppv Office

    Boehringer Ingelheim
    3+ years
    Not Disclosed
    Ingelheim am Rhein
    10 Dec. 6, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Lead EU-QPPV Office
    Company: Boehringer Ingelheim
    Location: Global

    Overview of the Role

    We are seeking a Lead EU-QPPV Office to join our Regional Pharmacovigilance (PV) and EU-QPPV Team. In this critical position, you will play a vital role in ensuring the effectiveness of Boehringer Ingelheim's global Pharmacovigilance system in compliance with regulatory requirements. Your responsibilities will include defining quality frameworks, coordinating PV inspections and audits, and leading the development of a global PSPV Training Strategy to ensure regulatory and compliance standards are met.

    This position requires a team-oriented professional with a structured, quality-driven mindset. If you are passionate about advancing PSPV quality in a dynamic and innovative environment, we invite you to join our mission of shaping the future of Patient Safety and Pharmacovigilance at Boehringer Ingelheim.

    Key Responsibilities

    Leadership and Quality Framework Management

    • Lead and provide guidance to the EU-QPPV Office team to ensure smooth operations.
    • Guarantee adherence to the BI Quality Management System (QMS) Framework.
    • Monitor and maintain an overview of the Pharmacovigilance System Performance.

    Inspection and Audit Coordination

    • Plan, coordinate, and oversee Pharmacovigilance inspections and internal/external audits.
    • Develop and implement best practices for PV Non-Compliance handling.

    Training and Compliance

    • Design and implement a global PSPV Training Strategy.
    • Ensure completion of compliance-relevant and ad-hoc training programs.
    • Oversee PV Quality Events and CAPA management, including centralized PV Non-Compliance reporting.

    PV System Maintenance

    • Maintain and update the PV system description in line with regulatory requirements.
    • Act as the Global Functional Vendor Manager (GFVM) for PSPV, ensuring effective collaboration with Quality Medicine Supplier Management.

    Stakeholder Engagement

    • Represent PV needs and gather feedback to optimize processes.
    • Build and strengthen networks with functions such as Quality Medicine and Regulatory Affairs to drive operational excellence.

    Qualifications

    Education and Experience

    • Master’s Degree in Life Sciences.
    • Extensive experience in Pharmacovigilance (local or global level), including PV auditing, inspections, compliance, CAPA management, and supplier management.

    Knowledge and Skills

    • In-depth understanding of PV regulations, compliance requirements, and system interfaces.
    • Proficiency in analyzing PV quality data, defining compliance indicators, and implementing process improvements.
    • Strong strategic and analytical thinking skills to identify and prioritize actions effectively.

    Interpersonal and Leadership Capabilities

    • Proven experience as a team leader with strong networking and communication skills.
    • Ability to influence, motivate, and collaborate across multidisciplinary teams.
    • Adaptability to dynamic environments with a focus on quality and compliance.

    Recruitment Process

    • Step 1: Online Application (Deadline: Mid-December 2024)
    • Step 2: Virtual Meeting (December 2024)
    • Step 3: On-site Interviews (January 2025)

    For questions, contact our HR Direct Team:

    Why Boehringer Ingelheim?

    At Boehringer Ingelheim, we develop therapies that improve the lives of humans and animals. Founded in 1885 and family-owned ever since, our mission is driven by 52,000 employees worldwide, fostering a diverse and inclusive culture that empowers innovation and collaboration.

    What We Offer:

    • Challenging and meaningful work in a collaborative global environment.
    • Opportunities for professional growth and development.
    • A culture that values diversity, equity, and inclusion.

    Equal Opportunity Employer
    We are committed to fostering a workplace that values diversity of thought, perspectives, and backgrounds. All qualified applicants are considered without regard to race, gender, age, disability, or other protected statuses.

    Learn more at Boehringer Ingelheim Careers.

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    Warsaw |

    Remote :

    Lousiana | Springville | Lenexa | Minnesota | Riga | Remote - South America (Latin Americal) | Xzagreb | Leinster | Remote | Melbourne | Remote - Europe | French | Nairobi | Castlebar | Faridabad | Remote - Africa | Belgium | Ireland | Bountiful | Hammond | Switzerland | Victoria | Hungary | Medan | Green Way | McFarland | Bishop | Slovakia | Manipal | Tulsa | Remote, USA | Thailand | Zaragoza | Texas | Remote - Middle East | Blue Bell |

    Bucharest :

    Bucharest |

    Makkah :

    Khulais | Najran | Jeddah | Riyadh | Rabigh | King Abdullah Economic City |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |