Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

Medpace, Inc.; München; Vor Ort; EUR 47.000 - 70.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Health, wellness, retirement and PTO

On-site mentors

Occasional WFH after training

Zusammenfassung

Medpace is expanding its European Pharmacovigilance activities and seeks a Clinical Safety professional to join the Clinical Safety team in London. The role involves handling SAE reports, generating narratives, and ensuring quality across safety data and documents.

You will work with Medical Monitors, QA, and Trial Management to drive project deliverables and sponsor meetings, while contributing to safety reporting for global trials and development programs.

Qualifikationen

• Bachelor’s degree in life sciences.
• 2+ years of clinical trial pharmacovigilance experience.
• Working knowledge of safety databases; Argus desirable.
• Strong knowledge of medical terminology and global safety reporting requirements.

Aufgaben

• Collect, process, and track SAE reports.
• Generate safety narratives and queries.
• Safety database data entry.
• Quality control of safety cases.
• Generate Investigator Safety Letters.
• SAE reconciliation between safety database and clinical database.
• TMF uploads and quality control review.
• Preparation of clinical safety documents (e.g., safety management plan, periodic safety reports).
• Attend sponsor TCs and audits/inspections.
• Lead clinical trial projects and provide oversight and compliance reports.
• Develop presentation materials for Sponsor meetings.
• Coordinate final medical review of study report narratives.
• Provide periodic safety summaries to project team.

Kenntnisse

Clinical safety

Pharmacovigilance

Medical terminology

Global trials

Ausbildung

Bachelor's degree in life sciences

Tools

Argus

Jobbeschreibung

Job Summary

At Medpace, our European Pharmacovigilance (PV) activities are growing rapidly. As such, we are searching for motivated individuals to join our Clinical Safety team in London. Working as part of a high performing group alongside Medical Monitors, Quality Assurance, Clinical Trial Management and others, this position plays a key role at Medpace to accomplish tasks and work on projects that are instrumental to the development of life changing medicines. If you want an exciting career where you can apply yourself to a variety of opportunities and develop new skills, then this is the opportunity for you!

Responsibilities

• Collect, process, and track serious adverse event (SAE) reports
• Generate safety narratives and queries
• Safety Database data entry
• Perform quality control of safety cases
• Generate Investigator Safety Letters
• SAE reconciliation between safety database and clinical database
• TMF uploads and quality control review
• Preparation of clinical safety documents as required (i.e., safety management plan, periodic safety reports and presentations)
• Attending internal and external meetings, as required (including sponsor TCs and audits/inspections)
• Leading clinical trial projects (ensure client deliverables are met, provide oversight and compliance reports)

Additional Responsibilities

• Develop presentation material and present during face-to-face Sponsor meetings (i.e., Kick-off Meetings, Investigator Meetings)
• Coordinate final medical review of study report narratives and submission to Medical Writers
• Develop drafts of adjudication material (i.e., charter, reporting materials)
• Provide periodic safety summaries to project Data Manager, Clinical Trial Manager, and Medical Monitor
• Train new Clinical Safety Coordinators on safety reporting responsibilities
• Coordinate safety responsibilities for aggregate reporting purposes (e.g., ensure timely data entry, tracking of pending cases, collaborate with Medical Monitor and Regulatory Affairs)

Qualifications

• Minimum Bachelor’s life science degree
• 2+ years of Clinical Trial Pharmacovigilance experience
• Working knowledge of Safety Databases (Argus is desirable)
• Demonstrate advanced knowledge of medical terminology, global safety reporting requirements and Good Clinical Practice (GCP) Guidelines
• Exposure to working on global trials as part of a multidisciplinary team

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.