Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Medpace; Stirling; Sur place; GBP 36 000 - 60 000; Plein temps

Avantages offerts par ce poste

Flexible work environment

Competitive compensation and benefits

Structured career paths

Company-sponsored events

Employee health and wellness

PTO

Résumé du poste

Medpace is expanding its European Pharmacovigilance activities and seeks motivated individuals to join our Clinical Safety team in Stirling, United Kingdom. You will work alongside Medical Monitors, QA, and Trial Management to ensure safety reporting and compliance across global trials.

Responsibilities include SAE processing, safety narratives, database QC, safety documents, and participation in sponsor meetings.

Qualifications

• 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.

Responsabilités

• Collect, process, and track 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 (e.g., safety management plan, periodic safety reports).
• Attend internal and external meetings (sponsor TCs and audits/inspections).
• Lead clinical trial projects to meet client deliverables and provide oversight.

Connaissances

Pharmacovigilance experience

GCP knowledge

Formation

Bachelor’s degree in life science

Outils

Argus

Description du poste

At Medpace, our European Pharmacovigilance (PV) activities are growing rapidly. As such, we are searching for motivated individuals to join our Clinical Safety team in Stirling. Working as part of a high performing group alongside Medical Monitors, Quality Assurance, Clinical Trial Management and others, this position plays a key role at Medpace to accomplish tasks and work on projects that are instrumental to the development of life changing medicines. If you want an exciting career where you can apply yourself to a variety of opportunities and develop new skills, then this is the opportunity for you!

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)

Additional Responsibilities

• 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)

Qualifications

• 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

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024

Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.