Clinical-Safety-Coordinator-Pharmacovigilance-Drug-Safety

0-2 years

Preferred by Comapny

Lombard

10 Nov. 25, 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 Opening: Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Location: London, United Kingdom
Department: Clinical Safety
Job ID: 9940

Overview

Medpace is seeking a motivated Clinical Safety Coordinator to join its growing European Pharmacovigilance (PV) team in London. This role offers a dynamic work environment, collaborating with Medical Monitors, Quality Assurance, Clinical Trial Management, and other multidisciplinary teams to support the development of life-changing medicines.

If you are passionate about clinical safety and want to apply your skills in a global setting while developing further, this opportunity is for you.

Key Responsibilities

Core Responsibilities:

SAE Management:
- Collect, process, and track serious adverse event (SAE) reports.
- Conduct SAE reconciliation between the safety database and clinical database.
Documentation and Reporting:
- Generate safety narratives, queries, and Investigator Safety Letters.
- Upload and perform quality control (QC) reviews of Trial Master File (TMF) documents.
- Draft clinical safety documents (e.g., safety management plans, periodic reports, presentations).
Database and Oversight:
- Perform safety database data entry and QC of safety cases.
- Coordinate final medical reviews and submissions for study reports.

Leadership and Coordination:

Lead clinical trial projects, ensuring client deliverables are met.
Provide oversight and compliance reporting for safety activities.
Train new Clinical Safety Coordinators in safety reporting responsibilities.

Additional Responsibilities:

Prepare and deliver presentations during sponsor meetings (e.g., Kick-Off Meetings, Investigator Meetings).
Collaborate on adjudication material development (e.g., charters, reporting materials).
Provide periodic safety summaries to internal teams, including Data Managers and Medical Monitors.

Qualifications

Education:
- Bachelor’s degree in a life science discipline.
Experience:
- Minimum 2+ years of pharmacovigilance experience in clinical trials.
- Familiarity with safety databases (e.g., Argus is preferred).
- Knowledge of global safety reporting requirements and Good Clinical Practice (GCP) guidelines.
Skills:
- Proficiency in medical terminology and global trial processes.
- Ability to work collaboratively in multidisciplinary teams.

Why Join Medpace?

Perks and Benefits

Flexible work environment.
Competitive compensation and benefits package.
Generous Paid Time Off (PTO).
Structured career paths with professional growth opportunities.
Participation in employee wellness programs and appreciation events.

Global Impact

Over 30 years of advancing therapeutic solutions.
Recognized as one of America’s Most Successful Midsize Companies (Forbes, 2021–2024).
Recipient of multiple CRO Leadership Awards for quality and reliability.

How to Apply

Interested candidates can apply for Job ID 9940 through the Medpace Career Portal.

Be part of a team that is transforming global healthcare and making a real difference in patients’ lives while advancing your career in pharmacovigilance.

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