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- Tasks: Join our Clinical Safety team to manage safety reports and support life-changing medicine development.
- Company: Medpace is a leading clinical research organisation dedicated to improving patient lives through innovative drug development.
- Benefits: Enjoy flexible work, competitive pay, career growth opportunities, and wellness initiatives.
- Why this job: Make a real impact in healthcare while developing valuable skills in a supportive team environment.
- Qualifications: A Bachelor's degree in life sciences and 2+ years of pharmacovigilance experience are required.
- Other info: Recognised by Forbes for excellence, Medpace offers a dynamic workplace with a focus on employee appreciation.
The predicted salary is between 36000 - 60000 £ per year.
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 London. 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 5,000 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
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.
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Clinical Safety Coordinator - Pharmacovigilance / Drug Safety employer: Medpace
Contact Detail:
Medpace Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
✨Tip Number 1
Familiarise yourself with the specific safety databases mentioned in the job description, particularly Argus. Having a solid understanding of how to navigate and utilise these systems will give you an edge during interviews.
✨Tip Number 2
Brush up on your knowledge of Good Clinical Practice (GCP) guidelines and global safety reporting requirements. Being able to discuss these topics confidently will demonstrate your expertise and commitment to the role.
✨Tip Number 3
Network with professionals already working in pharmacovigilance or clinical safety. Attend industry events or join relevant online forums to gain insights and potentially get referrals that could help you land the job.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios related to serious adverse event reporting and safety case management. Being ready to discuss real-life examples will showcase your practical experience and problem-solving skills.
We think you need these skills to ace Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Clinical Safety Coordinator position. Familiarise yourself with pharmacovigilance processes and the specific tasks mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical trials and pharmacovigilance. Emphasise your knowledge of safety databases and any specific tools or methodologies you've used that align with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for drug safety and your understanding of the role. Mention specific experiences that demonstrate your ability to handle serious adverse event reports and your familiarity with Good Clinical Practice guidelines.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in this field.
How to prepare for a job interview at Medpace
✨Know Your Pharmacovigilance Basics
Make sure you brush up on your knowledge of pharmacovigilance and drug safety. Be prepared to discuss serious adverse events (SAEs) and the importance of safety reporting in clinical trials, as this will likely come up during the interview.
✨Familiarise Yourself with Safety Databases
Since working knowledge of safety databases is a requirement, take some time to understand how they function, particularly Argus if possible. Being able to speak confidently about your experience with these systems will impress your interviewers.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle real-life situations in clinical safety. Think of examples from your past experiences where you successfully managed safety cases or collaborated with multidisciplinary teams.
✨Showcase Your Communication Skills
As a Clinical Safety Coordinator, you'll need to communicate effectively with various stakeholders. Prepare to demonstrate your communication skills by discussing how you've presented safety data or coordinated meetings in previous roles.