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Global Safety Lead

8-13 years
Not Disclosed
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
Location: Plainsboro, United States
Job Category: Regulatory Affairs & Safety Pharmacovigilance

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About the Department:

Our East Coast Global Development Hub in Lexington, MA and Plainsboro, NJ brings together leading minds in life science innovation. From early-stage research through late-stage clinical development, we support programs that shape the future of medicine. By merging the agility of biotech with the quality and stability of a large pharmaceutical company, our hub drives groundbreaking research across multiple therapeutic areas. At Novo Nordisk, we are committed to changing lives for the better. Are you ready to make a difference?


The Position:

We are seeking a Global Safety Lead to develop and execute the safety strategy for assigned programs within the East Coast Development Hub. You will collaborate with Global Safety Surveillance and cross-functional teams to ensure the ongoing safety assessment of products and molecules. As a motivated and science-driven leader, you will communicate safety information to both internal and external stakeholders while contributing to critical safety deliverables.


Key Responsibilities:

Establishing and Maintaining Safety Profiles:

  • Develop and update the minimum mandatory safety text (MMST) for use in Informed Consent documentation.
  • Own the safety sections of the Company Core Data Sheet (CCDS) for development products, and ensure safety labelling for marketed products.
  • Provide input into Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), SUSAR reports, and Risk Management Plans (RMPs).

Safety Surveillance:

  • Conduct ongoing safety surveillance for both pre-approval and post-approval products to identify, assess, and mitigate safety risks.
  • Perform periodic literature surveillance for marketed and development products.
  • Ensure safety monitoring in clinical trials, including dose escalation decisions for Phase I trials and providing safety input for Product Development Plans (PDPs) and Trial Protocols.

Stakeholder Engagement & Communication:

  • Chair and participate in cross-functional safety committees, ensuring safety monitoring across the product lifecycle.
  • Proactively engage with Health Authorities (HAs) and Ethics Committees (ECs) on safety aspects of clinical trials and protocols.
  • Provide safety training and communication, ensuring clarity of safety data to internal teams, external stakeholders, and investigators.

Project Coordination:

  • Represent safety in cross-functional project teams such as Global Project Teams (GPTs), ensuring alignment with safety deliverables and other project goals.
  • Ensure the integration of safety inputs into Risk-Based Monitoring and other aspects of development projects.

Qualifications:

Education & Experience:

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

Skills & Competencies:

  • Strong verbal and written communication skills, with the ability to convey complex safety data clearly to diverse stakeholders.
  • Excellent organizational and problem-solving abilities, with a demonstrated ability to thrive in a fast-paced environment.
  • Ability to maintain a positive attitude under pressure and adapt to changing priorities.

Why Join Novo Nordisk:

At Novo Nordisk, we are dedicated to creating an inclusive culture that celebrates the diversity of our employees, patients, and communities. We believe that a diverse workforce is key to creating innovative solutions and making a life-changing impact. If you're ready to be part of a dynamic team that’s transforming healthcare, we want to hear from you.