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    Clinical Safety Manager

    Medpace
    4+ years
    Preffered by Company
    Mumbai
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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: Clinical Safety Manager

    Location: India

    Company Overview:

    Medpace is a global leader in clinical contract research services, offering comprehensive Phase I-IV development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the development of safe and effective medical therapeutics through a rigorous and scientific approach. With headquarters in Cincinnati, Ohio, and operations in over 40 countries, we leverage our local expertise across a range of therapeutic areas including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

    Role Summary:

    We are seeking a full-time Clinical Safety Manager to join our Clinical Safety Department in India. In this pivotal role, you will manage a team of clinical safety professionals and oversee pharmacovigilance processes to ensure high-quality safety case management and reporting. This position offers the chance to leverage your nursing or pharmacovigilance expertise while advancing your career within a dynamic and growing organization.

    Responsibilities:

    • Team Leadership: Line manage, mentor, and develop a team of clinical safety professionals to enhance their skills and performance.
    • Client and Stakeholder Management: Maintain and manage relationships with clients and internal stakeholders by providing expert safety knowledge and support.
    • Safety Case Management: Oversee the clinical safety case management and aggregate reporting responsibilities of your team to ensure client needs are met with high quality.
    • Safety Management Plans: Create and implement safety management plans tailored to client requirements.
    • Document Review: Conduct safety reviews of clinical study documents, including protocols, study reports, and marketing application components.

    Qualifications:

    • Education: Bachelor’s degree in a healthcare-related field (e.g., Nursing, Pharmacy, Pharmacology).
    • Experience: At least 4 years of experience in clinical research or pharmacovigilance, with a minimum of 1 year of clinical nursing experience.
    • Project Management: Prior project management experience is preferred.

    Why Medpace?

    At Medpace, we are driven by People, Purpose, and Passion. Join us to make a meaningful impact on patient lives and advance your career in a supportive and innovative environment.

    Medpace Perks:

    • Work Flexibility: Hybrid work-from-home options available, depending on position and level.
    • Generous PTO: Competitive paid time off packages.
    • Employee Engagement: Company-sponsored employee appreciation events and health and wellness initiatives.
    • Work-Life Balance: Flexible work schedules and a competitive compensation and benefits package.
    • Career Development: Structured career paths with ample opportunities for professional growth.
    • Recognition and Awards:
      • Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
      • Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

    Join Us Today:

    If you are a skilled clinical safety professional with a passion for making a difference, we invite you to apply and become a key part of our team at Medpace.

    Make a Difference Tomorrow. Join Us Today.

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