Clinical Safety Manager - Pharmacovigilance / Drug Safety

Medpace; Wallend; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading clinical research organization in the UK is seeking a full-time Clinical Safety Manager to oversee clinical safety activities and ensure high-quality delivery. This role requires expertise in clinical safety, project management, and excellent communication skills. The ideal candidate should have a Bachelor's degree and experience managing clinical safety activities. Join a team that makes a difference in the medical field and enjoy a competitive compensation package.

Benefits

Flexible work environment

Competitive compensation and benefits package

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Qualifications

• Bachelor's degree or equivalent and clinical safety experience, including project management.
• Previous experience managing clinical safety activities for multiple programmes.
• Experience in writing departmental SOPs and Work Instructions.
• Comprehensive knowledge of global clinical safety regulatory requirements.

Responsibilities

• Manage clinical safety activities and multiple large programs.
• Oversee clinical safety case management and reporting responsibilities.
• Provide safety review of clinical study documents.
• Attend business development activities.

Skills

Clinical safety experience

Project management

Excellent verbal and written communication

Leadership and mentoring skills

Teamwork skills

Ability to work independently

Education

Bachelor's degree or equivalent

Job description

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 London. 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.

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, and 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

About Medpace

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