Medpace, Inc.
Clinical Safety Manager - Pharmacovigilance / Drug Safety
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Clinical Safety Manager
Our European activities are growing rapidly, and we are looking to hire a full-time, office-based Clinical Safety Manager to join our UK team and be based at our growing UK office in London. This position plays a crucial role in the pharmacovigilance process at Medpace, working within a team to support critical tasks and projects that drive the company’s success. Discover an exciting career opportunity to leverage your expertise and continue developing and growing your career.
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 on client needs
- 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 (Standard Operating Procedures) and Work Instructions
Qualifications
- Bachelor’s degree or equivalent, with clinical safety experience, including:
- Project management experience
- Ideally line management experience
- Previous experience in managing clinical safety activities for multiple programs
- Experience in writing departmental SOPs and Work Instructions
- Experience in PSMF (Pharmacovigilance System Master File) generation and maintenance
- Experience in CCDS (Clinical Case Data Sheet), RMP (Risk Management Plan), and SmPC (Summary of Product Characteristics) 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
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About Medpace
Medpace is a full-service clinical contract research organization (CRO), providing 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 a scientific and disciplined approach. We combine local regulatory expertise with expertise across major therapeutic areas, including:
- Oncology
- Cardiology
- Metabolic disease
- Endocrinology
- Central Nervous System (CNS)
- Anti-viral and anti-infective therapies
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Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 people across 40+ countries.
Why Join Medpace?
Our culture is built on three core elements: People, Purpose, and Passion, with the goal of making a difference tomorrow.
Impacting Lives
For over 30+ years, Medpace has contributed to improving the lives of countless patients and families dealing with hundreds of diseases across all key therapeutic areas. The work we do today will continue to positively impact 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
Recognition & Awards
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
- Frequently honored with CRO Leadership Awards by Life Science Leader magazine, based on:
- Expertise
- Quality
- Capabilities
- Reliability
- Compatibility
What To Expect Next
A Medpace team member will review your qualifications. If selected, you will be contacted with further details about the next steps.
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