Clinical Safety Manager - Pharmacovigilance / Drug Safety

Medpace, Inc.; Stirling; Sur place; GBP 40 000 - 80 000; Plein temps

Avantages offerts par ce poste

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Résumé du poste

An established industry player is seeking a dedicated Clinical Safety Manager to enhance their pharmacovigilance processes. This full-time role in Stirling offers the chance to manage clinical safety activities across multiple programs while collaborating with a dynamic team. You will utilize your expertise in project management and regulatory compliance to ensure the highest quality of service for clients. With a focus on professional growth and a supportive work environment, this opportunity allows you to make a significant impact in the clinical research field. Join a company recognized for its excellence and contribute to improving patient outcomes globally.

Qualifications

• Experience managing clinical safety activities across multiple programs.
• Strong knowledge of global clinical safety regulatory requirements.

Responsabilités

• Manage Clinical Safety activities and maintain high-quality client relationships.
• Oversee clinical safety case management and aggregate reporting.

Connaissances

Clinical Safety Management

Project Management

Regulatory Knowledge

Communication Skills

Leadership Skills

Teamwork

Independence

Formation

Bachelor’s degree or equivalent

Outils

SOP Writing

PSMF Generation

CCDS/RMP/SmPC Maintenance

Description du poste

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.

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