Clinical Safety Manager - Pharmacovigilance / Drug Safety

Medpace; München; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a forward-thinking organization as a Clinical Safety Manager in Munich, where your expertise will play a crucial role in ensuring the safety and efficacy of clinical trials. This exciting opportunity allows you to manage critical safety activities, oversee client relationships, and lead a team dedicated to excellence in pharmacovigilance. With a commitment to professional growth and a supportive work environment, you will have the chance to make a significant impact in the biotechnology and pharmaceutical industries. If you are passionate about making a difference and advancing your career, this role is perfect for you.

Leistungen

Flexible work environment

Competitive compensation and benefits

Competitive PTO packages

Structured career paths

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Qualifikationen

• 5 years of clinical safety experience with project management.
• Strong knowledge of global clinical safety regulations.

Aufgaben

• Manage Clinical Safety activities and relationships with clients.
• Oversee clinical safety case management and reporting.

Kenntnisse

Clinical Safety Management

Project Management

Leadership Skills

Communication Skills

Teamwork Skills

Regulatory Knowledge

Ausbildung

Bachelor's Degree

Master's Degree

Tools

SOP Writing

PSMF Management

CCDS/RMP/SmPC Writing

Jobbeschreibung

Job Summary

Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Manager to join our team in Munich. 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 can use your previous expertise and 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 and study reports.
• Create safety management plans dependent upon 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 and Work Instructions.

Please note this role is office-based in Munich.

Qualifications

• Bachelor’s degree and 5 years of clinical safety experience, including project management and ideally line management experience; OR
• Master's degree and 3 years of clinical safety experience, including project management and ideally line management experience.
• Previous experience of managing clinical safety activities for multiple programs.
• 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.

We kindly ask to submit applications in English.

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.

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.

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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