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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 advancing medical therapeutics globally.
- Benefits: Enjoy flexible work, competitive pay, career growth opportunities, and wellness initiatives.
- Why this job: Make a real impact on patients' lives while developing valuable skills in a dynamic environment.
- Qualifications: A Bachelor's in life sciences and 2+ years in Clinical Trial Pharmacovigilance are required.
- Other info: Be part of a recognised company with a strong reputation for quality and reliability.
The predicted salary is between 36000 - 60000 £ per year.
At Medpace, our European Pharmacovigilance (PV) activities are growing rapidly. 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)
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.
Contact Detail:
Medpace, Inc. 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 these systems work will give you an edge during interviews and demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals already working in pharmacovigilance or clinical safety. Attend industry events or webinars to connect with others in the field, as personal recommendations can often lead to job opportunities.
✨Tip Number 3
Brush up on your knowledge of Good Clinical Practice (GCP) guidelines and global safety reporting requirements. Being well-versed in these areas will not only help you in the application process but also prepare you for the responsibilities of the role.
✨Tip Number 4
Prepare to discuss your experience with serious adverse event (SAE) reporting and quality control processes during the interview. Be ready to provide examples of how you've handled similar tasks in previous roles to showcase your relevant 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 to thoroughly read the job description for the Clinical Safety Coordinator position. Understand the key responsibilities and qualifications required, such as experience in pharmacovigilance and knowledge of safety databases.
Tailor Your CV: Customise your CV to highlight relevant experience in clinical trials and pharmacovigilance. Emphasise your familiarity with medical terminology and any specific safety databases you have worked with, like Argus.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for drug safety and your motivation to join Medpace. Mention specific experiences that align with the responsibilities listed in the job description, such as generating safety narratives or leading clinical trial projects.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in the field of clinical safety.
How to prepare for a job interview at Medpace, Inc.
✨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, it’s crucial to understand how they function. If you have experience with Argus or similar systems, be ready to share specific examples of how you've used them in past roles.
✨Demonstrate Team Collaboration Skills
This role involves working closely with various teams, so highlight your experience in multidisciplinary settings. Prepare examples that showcase your ability to collaborate effectively with medical monitors, quality assurance, and clinical trial management.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about challenges you've faced in previous roles related to safety reporting and how you overcame them, as this will demonstrate your critical thinking abilities.
