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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

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Medpace

27d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • London

AI generated summary

  • You need a minimum Bachelor’s in life sciences, 2+ years in Pharmacovigilance, safety database knowledge (Argus preferred), and familiarity with medical terminology and GCP guidelines.
  • You will collect and track SAE reports, generate safety documents, perform database entry and quality checks, lead project oversight, and train new coordinators on safety reporting.

Requirements

  • Minimum Bachelor’s life science degree
  • 2+ years of Clinical Trial Pharmacovigilance experience
  • Working knowledge of Safety Databases (Argus is desirable)
  • Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines
  • Exposure to working on global trials as part of a multidisciplinary team

Responsibilities

  • Collect, process, and track serious adverse event (SAE) reports
  • Generate safety narratives and queries
  • Safety Database data entry
  • Perform quality control of safety cases
  • Generate Investigator Safety Letters
  • SAE reconciliation between safety database and clinical database
  • TMF uploads and quality control review
  • Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations)
  • Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)
  • Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)
  • Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)
  • Coordinate final medical review of study report narratives and submission to Medical Writers
  • Develop drafts of adjudication material (i.e., charter, reporting materials)
  • Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
  • Train new Clinical Safety Coordinators on safety reporting responsibilities
  • Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)

FAQs

What is the main role of a Clinical Safety Coordinator at Medpace?

The main role of a Clinical Safety Coordinator at Medpace involves collecting, processing, and tracking serious adverse event (SAE) reports, generating safety narratives, performing quality control of safety cases, and ensuring compliance with safety reporting requirements in clinical trials.

What are the required qualifications for this position?

The required qualifications for this position include a minimum of a Bachelor's degree in a life science, at least 2 years of Clinical Trial Pharmacovigilance experience, and a working knowledge of safety databases, preferably Argus.

Is prior experience with global clinical trials necessary?

Yes, exposure to working on global trials as part of a multidisciplinary team is an important qualification for this role.

What tools and software will I be using in this position?

You will be using safety databases for data entry and quality control. Familiarity with Argus is desirable.

What types of reports will I be responsible for generating?

You will be responsible for generating various safety reports, including Investigator Safety Letters, periodic safety reports, and safety management plans.

Will I be attending meetings and presentations as part of my job?

Yes, you will be required to attend internal and external meetings, including sponsor teleconferences, audits, and presentations during face-to-face sponsor meetings.

What opportunities for professional growth does Medpace offer?

Medpace offers structured career paths with opportunities for professional growth, competitive compensation, benefits packages, and various employee appreciation events.

What recognition has Medpace received as a company?

Medpace has been recognized by Forbes as one of America's Most Successful Midsize Companies for four consecutive years (2021-2024) and has received CRO Leadership Awards from Life Science Leader magazine.

What kind of work environment does Medpace provide?

Medpace provides a flexible work environment that encourages a collaborative and productive atmosphere.

Are there any health and wellness initiatives available to employees?

Yes, Medpace offers employee health and wellness initiatives to support the well-being of its staff.

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Medpace

Accelerating Drug, Biologic and Medical Device Clinical Development

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

Medpace is a UK-based clinical research organisation (CRO) that specializes in providing comprehensive and tailored services to pharmaceutical and biotechnology companies. Their ultimate mission is to accelerate the development of life-saving and life-improving therapies through high-quality and efficient clinical trials. Medpace's purpose is to collaborate with their clients to bring innovative medical treatments to market by offering expertise in study design, regulatory support, site management, and data analysis. They aim to advance medical knowledge and improve patient outcomes while upholding the highest ethical and scientific standards in clinical research within the UK and globally.

Culture & Values

  • People

    People are what matter. Our employees are our most important asset, and we recognize the importance of rewarding them not only by providing the opportunity to make a real difference in the health and well-being of people around the globe, but also by recognizing a job well done and offering a place to grow and thrive.

  • Community

    We are committed to making a difference in the communities we operate in. We provide financial and volunteer support for a variety of nonprofit organizations worldwide with a focus on health and local community-related efforts. Year after year we contribute time and funding to various causes and charities in our worldwide communities.

  • Compliance

    Honesty, confidentiality, integrity, and adherence to Medpace policies, standard operating procedures (SOPs) and applicable regulatory guidelines are our governing principles. We believe in a culture of compliance and are committed to ethical and compliant business practices by maintaining the highest standards for business conduct.

Benefits

  • Flexible Work Environment

    Productivity meets flexibility. Remote work and flexible schedules (dependent on position level). Relaxed dress code with business casual attire when working on campus.

  • State-of-the-Art Offices

    Our modern, eco-friendly, Cincinnati-based HQ campus offers an on-site fitness center and fitness classes, IT Support “genius bar”, restaurants, bars, and more. Medpace has invested in global office infrastructure with comfort, convenience, and productivity in mind.

  • Workplace Journey

    Structured career paths, mentorship, and opportunities for internal growth make Medpace the ideal place to develop and advance.

  • Training and Development

    Medpace provides tools and internal training to help employees professionally develop and succeed.

  • All the Perks

    Employer-sponsored events, happy hours, holiday celebrations, activities, and employee discounts on local sporting events, fitness gyms and studios, attractions, services, and nearby small businesses are just a part of what is available.

OpportunitiesView all