Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

2+ years

Not Disclosed

London

10 Nov. 22, 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 Title: Clinical Safety Coordinator
Company: Medpace
Location: London, UK

Job Summary
Medpace is expanding its European Pharmacovigilance (PV) activities and is looking for motivated individuals to join our Clinical Safety team in London. This position is crucial to the development of life-changing medicines and will involve working with a highly skilled team of professionals across various departments, including Medical Monitors, Clinical Trial Management, and Quality Assurance. If you’re looking for an exciting career where you can contribute to impactful projects and develop new skills, this is the opportunity for you!

Key Responsibilities

Collect, process, and track serious adverse event (SAE) reports.
Generate safety narratives and queries for SAE reports.
Enter data into Safety Databases and ensure data accuracy.
Perform quality control of safety cases.
Prepare and distribute Investigator Safety Letters.
Reconcile SAE data between safety and clinical databases.
Upload documents to the Trial Master File (TMF) and conduct quality control reviews.
Prepare clinical safety documents such as safety management plans and periodic safety reports.
Participate in internal and external meetings, including sponsor teleconferences (TCs) and audits/inspections.
Lead clinical trial projects ensuring client deliverables are met and provide oversight and compliance reports.

Additional Responsibilities

Develop presentation materials and present at Sponsor meetings (e.g., Kick-off Meetings, Investigator Meetings).
Coordinate the final medical review of study report narratives and submit them to Medical Writers.
Draft adjudication materials such as charters and reporting materials.
Provide periodic safety summaries to the project team, including Data Managers, Clinical Trial Managers, and Medical Monitors.
Train new Clinical Safety Coordinators on safety reporting responsibilities.
Manage safety responsibilities for aggregate reporting, ensuring timely data entry and tracking of pending cases.

Qualifications

Minimum Bachelor’s degree in Life Sciences.
At least 2 years of Clinical Trial Pharmacovigilance experience.
Working knowledge of Safety Databases (Argus is preferred).
Advanced understanding of medical terminology, global safety reporting requirements, and Good Clinical Practice (GCP) Guidelines.
Experience working on global trials as part of a multidisciplinary team.

Why Join Medpace?

Purposeful Work

Be part of a team dedicated to accelerating the development of safe and effective medical therapeutics.

Supportive Environment

Enjoy a flexible work environment and a competitive compensation package.
Benefit from structured career paths and ample opportunities for professional growth.
Participate in company-sponsored appreciation events and wellness initiatives.

About Medpace
Medpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We aim to accelerate the global development of medical therapeutics using a scientific and disciplined approach, with expertise in areas like oncology, cardiology, metabolic disease, endocrinology, CNS, and anti-infectives. Headquartered in Cincinnati, Ohio, we employ over 5,000 people across 40+ countries.

Awards & Recognition

Forbes ranked Medpace as one of America's Most Successful Midsize Companies (2021–2024).
We’ve received CRO Leadership Awards from Life Science Leader Magazine based on our expertise, quality, and reliability.

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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Job Description

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