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    Clinical Safety Manager - Pharmacovigilance / Drug Safety

    Medpace
    2+ years
    Not Disclosed
    London
    10 Oct. 23, 2024
    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 Summary
    We are excited to announce an opening for a full-time, office-based Clinical Safety Manager in our expanding UK office in London. This role is pivotal in the pharmacovigilance process at Medpace, where you will collaborate with a dedicated team to achieve critical tasks and projects that drive the company's success. If you’re seeking an exciting career to leverage your expertise and grow further, this is the opportunity for you!

    Responsibilities

    • Manage Clinical Safety activities and oversee multiple large programs.
    • Build and maintain relationships with clients and internal stakeholders by providing expert safety knowledge.
    • Oversee clinical safety case management and aggregate reporting to ensure high-quality fulfillment of client needs.
    • Conduct safety reviews of clinical study documents, including protocols, study reports, and marketing application components.
    • Develop safety management plans tailored to client requirements.
    • Participate in business development activities, including presentations to prospective sponsors, attending sponsor audits, and generating scopes of work and cost estimates.
    • Write and maintain departmental SOPs and Work Instructions.

    Qualifications

    • Bachelor’s degree or equivalent with clinical safety experience, including project management and ideally line management experience.
    • Proven track record in managing clinical safety activities for multiple programs.
    • Experience in writing departmental SOPs and Work Instructions.
    • Familiarity with PSMF generation and maintenance.
    • Expertise in CCDS/RMP/SmPC writing and maintenance.
    • Comprehensive knowledge of global clinical safety regulatory requirements.
    • Excellent verbal and written communication skills.
    • Strong leadership, mentoring, and motivational abilities.
    • Exceptional teamwork and the capacity to work independently.

    Medpace Overview
    Medpace is a full-service clinical contract research organization (CRO), offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across key areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

    Why Medpace?
    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

    Our work over the past 30+ years has positively impacted countless patients and families facing hundreds of diseases across key therapeutic areas. What we do today will improve the lives of individuals living with illness and disease in the future.

    Medpace Perks

    • Hybrid work-from-home options (dependent on position and level)
    • Competitive PTO packages
    • Company-sponsored employee appreciation events
    • Employee health and wellness initiatives
    • Flexible work schedules
    • Competitive compensation and benefits package
    • Structured career paths with opportunities for professional growth

    Awards

    • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
    • Continually honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

    Join Medpace and be part of a mission that makes a difference!

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