Clinical Safety Coordinator Job at Medpace, Inc. – in München
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.
Job Summary :
Our activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team! 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.
Collect, process and track Serious Adverse Event (SAE) reports;
Generate study report narratives and CIOMS-I forms;
Daily interaction with investigative sites;
Coordinate and prioritise daily project specific safety surveillance duties;
Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines;
Perform data entry of events into the EudraVigilance portal;
Regular interaction with other internal departments globally and locally, such as, Clinical Operations, Data Management and Regulatory Submissions;
Draft study specific safety documents as required.
Educated to degree level, Bachelor of Science;
Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology (preferred);
Knowledge of Electronic Data Capture (EDC) systems and other clinical databases (preferred);
Knowledge of applicable safety reporting guidelines (preferred).
Strong attention to detail;
3 years of experience of working within clinical safety;
Fluency in English;
Comprehensive understanding of Microsoft office suite;
Why Medpace? :
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Recognized by Forbes as one of America’s Best Mid-size Companies in 2021
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
EO/AA Employer M/F/Disability/Vets
- WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
Company: Medpace, Inc. –
Company Location: München