Senior Clinical Safety Coordinator

2 weeks ago

London, United Kingdom Page Group Full time

Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations).
- Coordinate final medical review of study report narratives and submission to Medical Writers.

**Client Details**

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 andeffective 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-viraland anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

**Description**
- 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).

**Profile**
- Bachelor's life science degree.
- Experience in Pre-Market Clinical Trial Pharmacovigilance (4+ years).
- 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 trails as part of a multidisciplinary team.

**Job Offer**
- Flexible work schedule.
- Medical and dental insurance.
- Company pension scheme.
- Cycle to work scheme.
- Annual salary review.
- Performance-based bonus.

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