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Global Program Safety Lead (All Genders / Full- Or Part-Time)

10+ years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MBBS/MD 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

Location: [Location] (Switzerland also considered)
Department: Healthcare


About Us:

At [Company Name], we are committed to transforming lives through innovative healthcare solutions. Our teams work passionately across six continents, focusing on key therapeutic areas such as Oncology, Neurology, and Fertility. Together, we create medicines, intelligent devices, and cutting-edge technologies that improve lives at every stage of life. If you're driven by the opportunity to make a meaningful impact, then join us in shaping the future of healthcare.


Your Role:

As a Global Program Safety Lead, you will be at the forefront of ensuring the safety of assigned products or portfolios. This role requires both innovative strategic input and scientific leadership to maintain the integrity of safety medical assessments. You will work closely with the Therapeutic Area Head to set the medical safety strategic direction, proactively manage safety signals, and address any safety concerns as they arise.

Key responsibilities include:

  • Safety Leadership: Provide innovative and strategic input to ensure the safety of products throughout their lifecycle, focusing on proactive safety signal management and benefit-risk analysis.
  • Collaboration: Work with R&D functions, contributing safety expertise to the Clinical Development Plan and cross-functional teams to ensure informed decision-making.
  • Benefit-Risk Analysis: Oversee benefit-risk analysis, contributing to key documents such as periodic safety reports, risk management plans, clinical trial protocols, and reports.
  • External Expertise: Engage with external experts and offer medical safety guidance for due diligence activities.
  • Decision Making: Exercise strong medical judgment in safety decision-making, ensuring the timely escalation of significant safety issues.

Who You Are:

  • Qualifications:

    • MD or equivalent with accredited residency.
  • Experience:

    • Minimum of 10 years in the pharmaceutical/biotech industry, with at least 5-6 years in Global Patient Safety (particularly in analysis and interpretation).
    • Extensive experience in safety monitoring and strategy during clinical drug development in the pharmaceutical, biotech, or CRO sectors.
  • Skills and Knowledge:

    • Mastery of global regulatory requirements for drug safety and pharmacovigilance.
    • Exceptional data analysis skills, with proficiency in signal detection and continuous benefit-risk assessment.
    • Strong medical judgment and experience in safety decision-making.
    • Proven experience leading cross-functional teams and influencing project outcomes.
    • Excellent written and oral communication skills in English.

What We Offer:

At [Company Name], we foster a culture of diversity, inclusion, and collaboration. We believe that diverse perspectives drive excellence and innovation, enabling us to lead in science and technology. Join our team and be part of a work environment that encourages personal development, growth, and global career opportunities.


Apply now and become part of our diverse team!
Join us in our mission to champion human progress and shape the future of healthcare.