At a Glance
- Tasks: Join our Clinical Safety team to ensure the safety of life-changing medicines.
- Company: Medpace, a leading clinical research organisation with a mission to improve patient outcomes.
- Benefits: Competitive pay, health benefits, flexible work options, and ongoing training.
- Other info: Dynamic workplace with clear career paths and mentorship opportunities.
- Why this job: Make a real impact in healthcare while developing your skills in a collaborative environment.
- Qualifications: Bachelor’s degree in life sciences and 2+ years in Clinical Trial Pharmacovigilance.
The predicted salary is between 63000 - 77000 £ 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
Why Medpace?
- When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
- Purpose-Driven Work Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
- Collaborative Culture Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust. Leadership throughout Medpace is both accessible and approachable
- Continuous Growth & Development Office based environment with on-site mentors. Defined career paths with clear advancement opportunities. Industry renowned onboarding and training programs designed to accelerate professional development. Ongoing training and continuous learning opportunities throughout your career. An environment that encourages employees to influence change, contribute ideas, and grow quickly.
Other Employee Benefits
- Competitive compensation programs that recognize and reward performance
- Comprehensive health, wellness, retirement, and PTO benefits
- Office based culture with occasional WFH that provides flexibility for eligible positions after training
- Company-sponsored social events
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Clinical Safety Coordinator - Pharmacovigilance / Drug Safety in City of London employer: Medpace, Inc.
Medpace, Inc. is an excellent employer for those looking to kickstart their career in clinical trials, offering comprehensive onboarding and training that empowers you to become a data monitoring expert. With a strong emphasis on cross-functional collaboration and a supportive work culture, employees are encouraged to grow and develop their skills in a dynamic environment. Located in a vibrant office setting, Medpace provides a unique opportunity to contribute meaningfully to impactful projects while enjoying a fulfilling work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Safety Coordinator - Pharmacovigilance / Drug Safety in City of London
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We think you need these skills to ace Clinical Safety Coordinator - Pharmacovigilance / Drug Safety in City of London
Some tips for your application 🫡
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Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Medpace, Inc.!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Medpace, Inc., we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Medpace, Inc.
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Medpace, Inc. that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
