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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 trials.
- Benefits: Enjoy flexible work, competitive pay, professional 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 in Clinical Trial Pharmacovigilance are required.
- Other info: Be part of a company recognised by Forbes for success and excellence in the industry.
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)
- 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
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.
Clinical Safety Coordinator employer: Medpace
Contact Detail:
Medpace Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Safety Coordinator
✨Tip Number 1
Familiarise yourself with the specific safety databases mentioned in the job description, particularly Argus. Having hands-on experience or knowledge about how these systems work will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals already working in pharmacovigilance or clinical safety roles. Attend industry events or webinars to connect with potential colleagues at Medpace, as personal referrals can often lead to job opportunities.
✨Tip Number 3
Brush up on your understanding of Good Clinical Practice (GCP) guidelines and global safety reporting requirements. Being able to discuss these topics confidently will demonstrate your commitment and readiness for the role.
✨Tip Number 4
Prepare to discuss your experience with serious adverse event (SAE) reporting and quality control processes in detail. Be ready to provide examples of how you've contributed to safety management in previous roles, as this will showcase your relevant expertise.
We think you need these skills to ace Clinical Safety Coordinator
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Safety Coordinator position at Medpace. Understand the responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 2+ years of Clinical Trial Pharmacovigilance experience. Be specific about your familiarity with safety databases and any relevant projects you've worked on that align with the responsibilities listed.
Use Medical Terminology: Since the role requires advanced knowledge of medical terminology and global safety reporting requirements, incorporate relevant terms and phrases into your application. This shows your understanding of the field and can set you apart from other candidates.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for making a difference in patients' lives. Mention why you are excited about the opportunity at Medpace and how you can contribute to their mission.
How to prepare for a job interview at Medpace
✨Know Your Pharmacovigilance Basics
Make sure you brush up on your knowledge of pharmacovigilance and safety reporting. Be prepared to discuss serious adverse events (SAEs) and how they are processed, 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, especially Argus if possible. Being able to speak confidently about your experience with these tools will impress your interviewers.
✨Highlight Your Teamwork Skills
This role involves collaboration with various teams, so be ready to share examples of how you've successfully worked in multidisciplinary teams before. Emphasise your ability to communicate effectively and coordinate with others.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of examples from your past experiences where you had to manage safety reports or lead projects, and be ready to explain your thought process.
