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For Companies At a Glance
- 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, professional 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 degree 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 28000 - 42000 £ per year.
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)
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.
EO/AA Employer M/F/Disability/Vets
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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 hands-on experience or even completing online tutorials can 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 join relevant online forums to gain insights and potentially get referrals that could boost your application.
✨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 will demonstrate your preparedness for the role.
✨Tip Number 4
Prepare to discuss your experience with serious adverse event (SAE) reporting in detail. Think of specific examples where you contributed to safety narratives or quality control processes, as this will showcase your relevant skills effectively.
We think you need these skills to ace Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Clinical Trial Pharmacovigilance. Emphasise any specific roles or projects that align with the responsibilities listed in the job description, such as safety database management or quality control.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your passion for drug safety and pharmacovigilance. Mention why you are interested in working at Medpace and how your skills can contribute to their mission.
Highlight Relevant Skills: In your application, clearly outline your knowledge of medical terminology, global safety reporting requirements, and Good Clinical Practice (GCP) guidelines. If you have experience with Safety Databases like Argus, make sure to mention it.
Showcase Teamwork Experience: Since the role involves working within a multidisciplinary team, provide examples of past experiences where you successfully collaborated with others. This could include leading projects or training new team members, which aligns with the responsibilities of the position.
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 tools will set you apart.
✨Prepare for Scenario-Based Questions
Expect to be asked how you would handle specific situations related to safety reporting or quality control. Think of examples from your past experience where you successfully managed similar challenges and be ready to share them.
✨Showcase Your Teamwork Skills
This role involves collaboration with various teams, so be prepared to discuss your experience working in multidisciplinary teams. Highlight any projects where you contributed to team success and how you communicated effectively with others.
