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Global Program Safety Lead - Immunology

10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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 Program Safety Lead – Immunology

Locations:

  • Primary Location: London, United Kingdom
  • Alternate Locations: Barcelona or Madrid, Spain
  • Working Model: Hybrid (Minimum 12 days per month in the office)

Note: Novartis does not provide relocation support for this role. Please apply only if the location is accessible for you.

Role Overview:

Novartis is seeking a Global Program Safety Lead (GPSL) – Immunology to serve as a scientific safety leader within the Immunology Medical Safety organization. The role focuses on safety surveillance, risk assessment, and regulatory compliance for clinical trials and post-marketing programs. The GPSL will play a key role in ensuring patient safety while contributing to Novartis' overall success.

🚀 Two positions available! 🚀


Key Responsibilities:

1. Safety Strategy & Program Oversight

  • Develop and implement safety surveillance strategies for assigned products.
  • Manage drug safety programs, ensuring proper follow-up on adverse reaction reports and regulatory compliance.
  • Oversee safety in clinical trials and post-marketing programs.
  • Provide safety expertise to the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) throughout the product life cycle.

2. Signal Detection & Risk Management

  • Monitor, evaluate, and interpret safety signals from clinical and post-marketing data.
  • Ensure early identification and management of potential safety risks.
  • Develop and lead risk management strategies for assigned compounds.

3. Regulatory Compliance & Documentation

  • Maintain accurate safety records and ensure compliance with regulatory guidelines.
  • Respond to inquiries from regulatory authorities and healthcare professionals regarding safety concerns.
  • Lead the development of safety strategies for health authority responses.

4. Cross-Functional Leadership & Collaboration

  • Contribute to and often lead the development of departmental and business unit goals.
  • Work closely with cross-functional teams, including clinical development, regulatory affairs, and medical strategy.
  • Provide expert guidance on safety science and risk management strategies.

5. Marketing Samples Distribution (if applicable)

  • Manage and oversee the distribution of marketing samples where required.

Required Qualifications & Experience:

Education:

  • Medical Degree (MD) required.

Professional Experience:

  • 8+ years of experience in the pharmaceutical industry (Big Pharma).
  • Strong background in clinical research, clinical trials, and regulatory compliance.
  • Proven leadership in functional teams and cross-departmental collaboration.

Key Skills & Competencies:

  • Safety Science & Risk Management
  • Regulatory Compliance & Process Safety Management
  • Medical Strategy & Clinical Research
  • Leadership & Functional Team Management

Language Requirements:

  • Fluent English (spoken and written) is mandatory.
  • Additional languages are an advantage.

Why Join Novartis?

💡 Make an impact on patients' lives through innovative safety evaluation.
🌍 Work in a dynamic, global environment with top industry professionals.
📈 Develop and grow in a leading pharmaceutical company.
🏡 Hybrid working model offering flexibility.

Diversity & Inclusion Commitment

Novartis is committed to fostering a diverse and inclusive workplace, representing the patients and communities we serve.

🔗 Apply now and be a part of shaping the future of immunology safety!