At a Glance
- Tasks: Manage clinical safety activities and oversee multiple large programmes in a dynamic team.
- 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 patient lives while developing your career in a supportive environment.
- Qualifications: Bachelor's degree with clinical safety experience; strong leadership and communication skills required.
- Other info: Join a company recognised by Forbes for its success and commitment to quality.
The predicted salary is between 36000 - 60000 £ per year.
Job Summary
Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our UK team and to be based at our growing UK office in Stirling. This position plays a key role in the pharmacovigilance process at Medpace. Working in a team to accomplish tasks and projects that are instrumental to the company\’s success.
If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Manage Clinical Safety activities and multiple large programs
- Manage relationships with clients and internal stakeholders by providing expert safety knowledge;
- Oversee clinical safety case management and aggregate reporting responsibilities to ensure client needs are fulfilled to a high quality;
- Provide safety review of clinical study documents, including protocols, study reports; and marketing application components.
- Create safety management plans dependent upon client;
- Attend business development activities such as presentations to prospective Sponsors, participation in Sponsor audits, generation of scope of work and cost estimates
- Write departmental SOPs and Work Instructions
Qualifications
- Bachelor\’s degree or equivalent and clinical safety experience, including project management and ideally line management experience;
- Previous experience of managing clinical safety activities for multiple programmes;
- Experience in writing departmental SOPs and Work Instructions;
- Experience in PSMF generation and maintenance;
- Experience in CCDS/RMP/SmPC writing and maintenance;
- Comprehensive knowledge of global clinical safety regulatory requirements;
- Excellent verbal and written communication skills;
- Strong leadership, mentoring, and motivational skills;
- Exceptional teamwork skills;
- Ability to work independently.
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. #J-18808-Ljbffr
Clinical Safety Manager - Pharmacovigilance / Drug Safety employer: Medpace, Inc.
Contact Detail:
Medpace, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Safety Manager - Pharmacovigilance / Drug Safety
✨Tip Number 1
Familiarise yourself with the latest pharmacovigilance regulations and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the clinical safety and pharmacovigilance sectors. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends, which can give you an edge during discussions.
✨Tip Number 3
Prepare to discuss specific examples of your previous experience managing clinical safety activities. Highlighting your project management skills and how you've successfully led teams will resonate well with the hiring managers.
✨Tip Number 4
Research Medpace's recent projects and achievements in the clinical research field. Being knowledgeable about the company’s work will allow you to tailor your conversations and show genuine interest in contributing to their mission.
We think you need these skills to ace Clinical Safety Manager - Pharmacovigilance / Drug Safety
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant clinical safety experience, particularly in pharmacovigilance and project management. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical safety and your understanding of the pharmacovigilance process. Mention specific experiences that align with the responsibilities listed in the job description.
Highlight Relevant Skills: Emphasise your leadership, mentoring, and communication skills in your application. Provide examples of how you've successfully managed relationships with clients and stakeholders in previous roles.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical safety roles.
How to prepare for a job interview at Medpace, Inc.
✨Showcase Your Clinical Safety Knowledge
Make sure to brush up on your understanding of pharmacovigilance and clinical safety regulations. Be prepared to discuss your previous experiences managing clinical safety activities and how they relate to the role.
✨Demonstrate Strong Communication Skills
Since this role involves managing relationships with clients and stakeholders, practice articulating your thoughts clearly. Prepare examples of how you've effectively communicated complex safety information in the past.
✨Highlight Leadership and Teamwork Experience
This position requires strong leadership and teamwork skills. Think of specific instances where you led a project or collaborated with a team to achieve a common goal, and be ready to share these stories.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world situations. Consider potential challenges in clinical safety management and how you would address them, showcasing your critical thinking skills.