At a Glance
- Tasks: Join our Clinical Safety team to track and manage safety reports for life-changing medicines.
- Company: Medpace, a leading company in Pharmacovigilance with a dynamic team in London.
- Benefits: Exciting career opportunities, skill development, and a collaborative work environment.
- Other info: Work with a high-performing team and gain exposure to global clinical trials.
- Why this job: Make a real impact on global health by ensuring drug safety and compliance.
- 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
Clinical Safety Coordinator - Pharmacovigilance / Drug Safety employer: Medspace
At Medpace, we pride ourselves on being an exceptional employer, offering a dynamic work environment in London where innovation and collaboration thrive. Our Clinical Safety Coordinators benefit from a supportive culture that encourages professional growth through diverse opportunities in pharmacovigilance, alongside a team of dedicated experts committed to developing life-changing medicines. With a focus on employee development and a commitment to quality, Medpace stands out as a rewarding place to advance your career in the clinical research field.
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 candidates who can demonstrate their expertise through real examples, so don’t hold back!
✨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 motivated individuals like you to join our Clinical Safety team, 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 experience in pharmacovigilance and any relevant skills that match the job description. We want to see how your background aligns with our needs!
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 skills can contribute to our team at Medpace. Keep it engaging and personal – we love to see your personality!
Showcase Relevant Experience:When detailing your work history, focus on your clinical trial experience and any specific projects you've led. We’re looking for candidates who can demonstrate their understanding of safety databases and GCP guidelines, so don’t hold back!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Medspace
✨Know Your Stuff
Make sure you brush up on your knowledge of pharmacovigilance and drug safety. Familiarise yourself with the key responsibilities listed in the job description, like SAE reporting and safety narratives. This will show that you're not just interested in the role but also understand what it entails.
✨Showcase Your Experience
Prepare to discuss your previous experience in clinical trials and pharmacovigilance. Have specific examples ready that highlight your skills in data entry, quality control, and working with safety databases. This will help you demonstrate your fit for the role and how you can contribute to the team.
✨Ask Smart Questions
During the interview, don’t hesitate to ask insightful questions about the team dynamics or ongoing projects at Medpace. This shows your enthusiasm for the role and helps you gauge if the company culture aligns with your values.
✨Practice Your Presentation Skills
Since the role involves developing presentation materials and presenting during meetings, practice your presentation skills beforehand. You might even want to prepare a mock presentation on a relevant topic to showcase your ability to communicate effectively.
