- Oversight of submission of safety reports in the appropriate format to Competent Authorities/Ethics Committees in compliance with regulatory timelines;
- 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.
- Work in a global team to distribute safety reports globally
- Educated to degree level, Bachelor of Science;
- Demonstrate fundamental knowledge of Good Clinical Practice (GCP) guidelines and medical terminology;
- Knowledge of Electronic Data Capture (EDC) systems and other clinical databases;
- Experience safety reporting to regulatory authorities in Spanish speaking LATAM countries;
- Drug safety experience;
- Knowledge of applicable safety reporting guidelines;
- Strong attention to detail;
- 3 years of experience of working within drug safety;
- Fluency in Spanish
Experienced Clinical Safety Coordinator - Xico, México - Medpace, Inc.
Descripción
Job Summary Our Latin American 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.
ResponsibilitiesOur 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? 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.
Organic Growth:
Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH.
In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.Perks (vary by location and position): On-site fitness center(s)
Campus walking pathsCompany-sponsored social and wellness eventsOfficial Sponsor of FC CincinnatiHybrid work-from-home options and flexible work scheduleOn-site Market PlaceFree and covered parkingDiscounts for local businessesOn campus restaurants and banks coming soonAwards:
Medpace historically named a Top Cincinnati Workplace by the Cincinnati EnquirerRecognized by Forbes as one of America's Best Mid-size Companies in 2021Medpace 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 availabilityContinually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityRanked in the top 10 on the 2021 LinkedIn Top Companies list in CincinnatiWhat to
Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
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