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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. 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. #J-18808-Ljbffr
Clinical Safety Coordinator - Pharmacovigilance / Drug Safety employer: Medpace, Inc.
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 hands-on experience or even a solid understanding of how these systems work can set you apart from other candidates.
✨Tip Number 2
Network with professionals in the pharmacovigilance field, especially those who have experience at Medpace or similar organisations. Attend industry conferences or webinars to make connections and learn more about the company culture and expectations.
✨Tip Number 3
Brush up on your knowledge of Good Clinical Practice (GCP) guidelines and global safety reporting requirements. Being able to discuss these topics confidently during interviews will demonstrate your commitment and expertise in the field.
✨Tip Number 4
Prepare to showcase your teamwork skills, as this role involves collaboration with various departments. Think of examples from your past experiences where you successfully worked in a multidisciplinary team and be ready to share them during your interview.
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 of a Clinical Safety Coordinator. 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 like Argus that are mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for drug safety and your motivation to join Medpace. Mention how your skills align with their mission and the impact you hope to make in the role.
Highlight Relevant Qualifications: In your application, clearly state your educational background and any certifications related to life sciences or clinical research. Make sure to include your experience with Good Clinical Practice (GCP) guidelines and any global trial exposure.
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. Understand the key responsibilities of a Clinical Safety Coordinator, such as SAE reporting and safety database management. This will show your interviewer that you're serious about the role.
✨Familiarise Yourself with Medpace
Research Medpace's mission, values, and recent projects. Being able to discuss how your skills align with their goals will demonstrate your genuine interest in the company and the position.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle real-life situations in clinical trials. Think of examples from your past experience where you successfully managed adverse events or collaborated with multidisciplinary teams.
✨Showcase Your Communication Skills
As a Clinical Safety Coordinator, you'll need to communicate effectively with various stakeholders. Be prepared to discuss how you've developed presentation materials or led meetings in the past, highlighting your ability to convey complex information clearly.
