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    Global Safety Lead

    Novo Nordisk
    8-13 years
    Not Disclosed
    Lexington
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Title: Global Safety Lead - U.S. East Coast Development Hub
    Location: Lexington, United States
    Job Category: Regulatory Affairs & Safety Pharmacovigilance

    Apply Now

    About the Department:

    The East Coast Global Development Hub at Novo Nordisk brings together top-tier minds in life science innovation, with facilities in Lexington, MA and Plainsboro, NJ. We support programs across all stages of clinical development, from early research to late-stage trials. Our goal is to create a future-focused R&D community based on collaboration and cutting-edge research across various innovative modalities and therapeutic areas. By merging biotech speed and agility with large pharmaceutical company resources and stability, we’re shaping the future of medicines and improving lives. Are you ready to make a difference?

    The Position:

    As a Global Safety Lead, this leadership role will focus on developing and overseeing safety strategies and major deliverables for assigned programs within the U.S. East Coast Development Hub. You will be a collaborative, science-driven expert responsible for the ongoing assessment of safety profiles for assigned molecules/products and communicating safety information to both internal and external stakeholders.

    Key Responsibilities:

    Safety Strategy & Profile Management:

    • Establish the safety profile for products and develop mandatory safety text (MMST) for informed consent.
    • Own safety sections of labeling for the evolving Company Core Data Sheet (CCDS) for development products.
    • Maintain the labeling for marketed products and participate in the Product Labeling Committee (PLC) Review Group.
    • Provide ongoing safety surveillance during both pre-approval and post-approval phases for Novo Nordisk products.

    Surveillance & Risk Mitigation:

    • Perform ongoing safety surveillance across accessible data and take initial actions to mitigate risks when safety signals or alerts are detected.
    • Conduct periodic literature reviews for marketed and development products, providing input for Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).
    • Respond to inquiries from health authorities (HAs) and internal Novo Nordisk affiliates regarding safety aspects of products.

    Clinical Trials & Safety Communication:

    • Act as a member of the Trial Safety Group for dose escalation decisions in Phase I trials.
    • Provide safety input to key documents such as Product Development Plans (PDP), Trial Protocols, and Clinical Trial Reports (CTRs).
    • Support proactive safety communication by participating in project and trial groups, offering safety training as needed.
    • Address inquiries from HAs and Ethics Committees (ECs) regarding safety protocols, Patient Information, and Informed Consent.

    Cross-functional Collaboration & Leadership:

    • Chair or participate in cross-functional safety committees and manage safety input throughout the lifecycle of products.
    • Serve as the safety representative in trial squads and Global Project Teams (GPT), ensuring coordination across various deliverables.
    • Contribute to Risk-Based Monitoring activities across development projects, ensuring safety input is integrated at all stages.

    Qualifications:

    Education & Experience:

    • MD, PhD, or equivalent degree with 8+ years of experience in global safety surveillance and/or clinical/drug development.
    • Alternatively, a life sciences/pharmacy nursing degree with 13+ years of relevant experience.

    Skills & Competencies:

    • Excellent verbal and written communication skills.
    • Strong organizational and problem-solving abilities.
    • Capacity to thrive in a busy, high-pressure environment while maintaining a positive attitude.
    • Demonstrated leadership in global safety surveillance and a proven track record in cross-functional collaboration.

    Why Novo Nordisk:

    At Novo Nordisk, we aspire to be the best company for the world. Our inclusive and diverse work culture is built on innovation, where every employee’s unique perspective is valued. Together, we aim to change lives by addressing the needs of our patients and communities worldwide.

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    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    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 :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |