At a Glance
- Tasks: Join our Clinical Safety team to track and manage safety reports for life-changing medicines.
- Company: Medpace, a leader in Pharmacovigilance with a dynamic and supportive culture.
- Benefits: Flexible work environment, competitive pay, and structured career growth opportunities.
- Other info: Engage in exciting projects and enjoy company-sponsored events focused on employee wellness.
- Why this job: Make a real impact in drug safety while developing valuable skills in a collaborative setting.
- Qualifications: Bachelor’s degree in life sciences and 2+ years in Clinical Trial Pharmacovigilance.
The predicted salary is between 30000 - 40000 € per year.
Department: Clinical Safety
Location: Stirling
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
Benefits
- 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 in Stirling employer: Medspace
At Medpace, we pride ourselves on being an exceptional employer, offering a dynamic work environment in Stirling where our Clinical Safety team plays a pivotal role in the development of life-changing medicines. With a strong focus on employee growth, we provide structured career paths, competitive compensation, and a flexible work culture that fosters collaboration and innovation. Join us to be part of a high-performing team dedicated to making a meaningful impact in the field of pharmacovigilance.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Safety Coordinator - Pharmacovigilance / Drug Safety in Stirling
✨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 or even in front of the mirror to boost your confidence!
✨Tip Number 3
Showcase your skills during interviews by sharing specific examples from your past experiences. We love hearing about how you’ve tackled challenges in clinical trials or improved safety reporting processes.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate individuals ready to make a difference in drug safety.
We think you need these skills to ace Clinical Safety Coordinator - Pharmacovigilance / Drug Safety in Stirling
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. We want to see how you can contribute to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical safety and how your background makes you a great fit for Medpace. We love seeing enthusiasm and a personal touch!
Showcase Your Skills:In your application, don’t forget to showcase your knowledge of safety databases and medical terminology. If you've worked on global trials or have experience with GCP guidelines, let us know! We’re looking for candidates who can hit the ground running.
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. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Medspace
✨Know Your Stuff
Make sure you brush up on your knowledge of pharmacovigilance and clinical safety. Familiarise yourself with key terms like serious adverse events (SAEs) and safety databases, especially Argus if you can. This will show that you're not just interested in the role but also understand the industry.
✨Showcase Your Experience
Prepare to discuss your previous experience in clinical trials and how it relates to the responsibilities listed in the job description. Be ready to share specific examples of how you've handled SAE reports or worked with multidisciplinary teams. This will help demonstrate your practical skills and readiness for the role.
✨Ask Smart Questions
Come prepared with insightful questions about the team dynamics, ongoing projects, or the company’s approach to safety reporting. This shows your genuine interest in the position and helps you gauge if the company is the right fit for you.
✨Practice Your Presentation Skills
Since the role involves developing presentation materials and presenting during meetings, practice articulating your thoughts clearly and confidently. You might even want to prepare a mock presentation on a relevant topic to showcase your communication skills during the interview.
