At a Glance
- Tasks: Join our Clinical Safety team to track and process safety reports for life-changing medicines.
- Company: Medpace, a rapidly growing company in European Pharmacovigilance.
- Benefits: Flexible work environment, competitive pay, and structured career paths.
- Other info: Enjoy employee appreciation events and wellness initiatives.
- Why this job: Make a real impact on global health while developing your skills in a dynamic team.
- Qualifications: Bachelor’s degree in life sciences and 2+ years in Clinical Trial Pharmacovigilance.
The predicted salary is between 37000 - 45000 € 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 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
Clinical Safety Coordinator - Pharmacovigilance / Drug Safety employer: Medpace, Inc.
At Medpace, we pride ourselves on being an exceptional employer, offering a dynamic work environment in London where our Clinical Safety Coordinators can thrive. With a strong focus on employee growth, we provide structured career paths, competitive compensation, and a range of health and wellness initiatives, all while working alongside a talented team dedicated to developing life-changing medicines. Join us for a rewarding career that not only values your contributions but also supports your professional development through various opportunities and company-sponsored events.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Safety Coordinator - Pharmacovigilance / Drug Safety
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Clinical Safety Coordinator role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of safety databases and GCP guidelines. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during those crucial moments.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your experience in clinical trials and pharmacovigilance. We love seeing tangible evidence of your work, so don’t hold back on sharing your achievements during interviews.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. We’re always on the lookout for passionate individuals ready to make a difference in drug safety, so don’t miss out!
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 is tailored to the Clinical Safety Coordinator role. Highlight your relevant experience in pharmacovigilance and any specific skills that match the job description, like your knowledge of safety databases or clinical trial management.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about drug safety and how your background makes you a perfect fit for our team at Medpace. Don’t forget to mention any exciting projects you've worked on!
Showcase Your Skills:In your application, be sure to showcase your skills in quality control and data entry. Mention any experience you have with generating safety narratives or preparing clinical safety documents, as these are key responsibilities for the role.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Medpace, Inc.
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge and the specific responsibilities of a Clinical Safety Coordinator. Familiarise yourself with safety databases like Argus, and be ready to discuss your experience with serious adverse event reports and quality control processes.
✨Showcase Your Team Spirit
Since this role involves working closely with various teams, be prepared to share examples of how you've collaborated in the past. Highlight any experiences where you’ve worked with Medical Monitors or Quality Assurance teams, as this will show you understand the importance of teamwork in clinical trials.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about how you would handle discrepancies in safety data or how you would approach training new team members. Practising these scenarios can help you articulate your thought process clearly.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that demonstrate your interest in the role and the company. Inquire about the team dynamics, ongoing projects, or how Medpace supports professional development. This shows you’re not just interested in the job, but also in growing with the company.
