Clinical Safety Manager - Pharmacovigilance / Drug Safety

Medpace; München; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Flexible work environment

Competitive compensation and benefits package

Structured career paths with opportunities for growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Employee health and wellness

Zusammenfassung

A leading contract research organization is seeking a full-time, office-based Clinical Safety Manager in Munich. This role involves managing clinical safety activities, client relationships, and overseeing case management. Candidates should have a Bachelor's degree with at least 5 years in clinical safety or a Master's with 3 years of experience, including project management. The position offers a competitive advantage with flexible work, professional development opportunities, and a strong company culture focused on improving lives.

Qualifikationen

• 5+ years of clinical safety experience with project management.
• Experience in writing departmental SOPs and Work Instructions.
• Comprehensive knowledge of clinical safety regulatory requirements.
• 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 and ability to work independently.

Aufgaben

• Manage Clinical Safety activities and multiple large programs.
• Oversee clinical safety case management and reporting responsibilities.
• Attend business development activities and conduct presentations.
• 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.
• Please note this role is office-based in Munich.

Kenntnisse

Leadership

Project Management

Communication

Teamwork

PSMF/SmPC writing

Global regulatory knowledge

Leadership

Teamwork

Independent work

Communication skills

Ausbildung

Bachelor's degree in relevant field

Master's degree in relevant field

Jobbeschreibung

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 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

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. 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.