Clinical Safety Manager - Pharmacovigilance / Drug Safety

Medpace, Inc.; München; Vor Ort; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

Medpace is seeking a full-time, office-based Clinical Safety Manager in Munich to lead pharmacovigilance activities and support safety programs across multiple studies.

You will collaborate with clients and internal teams, review safety data, prepare reports, and contribute to safety plans and regulatory submissions. This role offers growth within a globally recognized CRO and requires strong leadership and independent work in a fast-paced environment.

Qualifikationen

• Bachelor’s degree and 5 years of clinical safety experience, including project management and ideally line management experience.
• Master's degree and 3 years of clinical safety experience, including project management and ideally line management experience.
• Experience 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.

Aufgaben

• 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

Kenntnisse

Clinical safety

Project management

Leadership

Communication skills

Teamwork

Independent work

SOP writing

Regulatory knowledge

Ausbildung

Bachelor's degree in life sciences or related field

Master's degree in life sciences or related field

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 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) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.