Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
Job Summary :
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)
- 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)
- 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 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.
The work we’ve done over the past 30\+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. 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
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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