Global Pharmacovigilance Coordinator
4 hours ago
Job Overview: Medpace, Inc. is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. As a Global Pharmacovigilance Coordinator, you will play a critical role in accelerating the global development of safe and effective medical therapeutics through scientific and disciplined approach.
Main 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.
- Attending internal and external meetings.
- Leading clinical trial projects.
Additional Responsibilities:
- Develop presentation material and present during face-to-face Sponsor meetings.
- Coordinate final medical review of study report narratives and submission to Medical Writers.
- Develop drafts of adjudication material.
- 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.
Qualifications: To succeed in this role, you should hold a Bachelor's degree in life sciences, have 2+ years of experience in Clinical Trial Pharmacovigilance, and possess working knowledge of Safety Databases. Additionally, you should demonstrate advanced knowledge of medical terminology, global safety reporting requirements, and Good Clinical Practice (GCP) Guidelines.
Benefits: As a valued member of our team, you can expect a competitive salary range of £35,000 - £50,000 per annum, flexible work environment, competitive compensation and benefits package, PTO packages, structured career paths with opportunities for professional growth, company-sponsored employee appreciation events, and employee health and wellness initiatives. In addition, we are recognized by Forbes as one of America's Most Successful Midsize Companies and continually recognized with CRO Leadership Awards from Life Science Leader magazine.
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