Medpace, Inc.
Clinical Safety Manager - Pharmacovigilance / Drug Safety
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Clinical Safety Manager - Pharmacovigilance / Drug Safety
Clinical Safety Manager -- Full-Time, Office-Based Role --
Our European activities are expanding rapidly, and we’re seeking a Clinical Safety Manager to join our UK team, based at our growing office in Stirling. This critical role drives our pharmacovigilance efforts, ensuring medication safety at scale. Join a company where your expertise can grow alongside our ambitions in an environment that values career development and team collaboration.
About the Role
As a Clinical Safety Manager, you play an essential part in shaping Medpace’s pharmacovigilance process by managing clinical safety activities and delivering support across large, diverse programs. Your contributions span clinical safety governance, stakeholder partnerships, and regulatory compliance. This is an opportunity to leverage your past experience while taking ownership of training, mentoring, and guiding high-performing teams—all within a company earnestly committed to accelerating life-saving medical therapeutics.
Responsibilities
Core Duties
- Manage large-scale clinical safety programs, ensuring alignment with global regulatory requirements and client expectations.
- Lead stakeholder engagement, providing clinical safety expertise to internal teams and external Sponsor relationships.
- Oversee case management and aggregate reporting to meet high standards of accuracy and timeliness, fulfilling client needs.
- Perform pre-submission reviews of clinical documentation, including study protocols, study reports, and safety sections of marketing applications (e.g., SmPC/RMP).
- Develop, implement, and maintain custom safety management plans tailored to client needs, supported by regulatory insights.
- Engage in business development activities, such as pitching to prospective Sponsors, auditing processes, and drafting scope of work and cost proposals.
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Process Governance
- Draft and maintain Standard Operating Procedures (SOPs) and Work Instructions for internal compliance.
- Support electronic case reporting systems (e.g., CCDS) to ensure data accuracy and timelines.
Requirements
Qualifications & Experience
- Bachelor’s degree (or equivalent) in a clinical, pharmaceutical, or regulatory science field.
- Proven clinical safety experience, with an emphasis on project management and stakeholder leadership—preferably including team line-management experience.
- Demonstrated ability to manage multiple large pharmacovigilance programs concurrently.
- Hands-on experience in the production and oversight of:
- Safety Management Plans (PSMF)
- Post-authorisation safety documentation (RMP revision, SmPC-outlining)
- Expert grasp of global regulatory landscapes, including ICH-GCP, E2B, ICH E2C(R3), and regional agency guidelines.
- Advanced proficiency in consultative skills, including written reporting, presentations, and audit readiness.
- Highly organised with the ability to work individually or lead cross-functional teams.
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Why Join Medpace?
Innovation at Scale
Medpace is a global leader in Phase I–IV clinical trials, supporting innovation across oncology, cardiology, CNS, and rare diseases. Our work impacts millions of lives affected by chronic illnesses—every project brings us one step closer to safer treatments for patients today and tomorrow.
Perks & Culture
- Flexibility: Adapt your working environment to suit your needs, with options for hybrid roles.
- Growth: Clear career progression paths backed by structured training and acceleration of expertise.
- Wellbeing: Employee wellness programs, recreational challenges, and shared appreciation events.
- Compensation: Competitive salary, progress bonuses, strong PTO policies, and healthcare benefits.
Reputation & Recognition
- Ranked among America’s Most Successful Midsize Companies (Forbes, 2021–2024).
- Named a CRO Leadership Award winner annually for our capabilities and client compatibility.
Next Steps
If this role resonates, contact our recruiting team for an informal discussion and potential next steps. We’re eager to hear how your skills align with this vital role—where your expertise advances Medpace and global healthcare.
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