Job Description

Job Summary :
We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our team in Singapore office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Responsibilities :

• Working closely with the Clinical Safety Manager to ensure each project deliverables are met in relation to safety activities in Japan;
• Collect, process, and track serious adverse event (SAE) reports, literature and ‘measures taken’;
• Generate and track study report safety narratives;
• Generate Investigator Safety Line Listings and PMDA forms for distribution to health authority;
• Assist in preparation of clinical safety documents
• Perform safety submissions of expedited/periodic reports to PMDA, Investigators/Heads of Sites in Japan

Qualifications :

• Bachelor’s degree in health/life sciences with 1 year of clinical safety experience or 2 years of pharmaceutical research experience (minimum);
• Proficient in a range of Clinical Safety tasks, as detailed in the ‘responsibilities’ section (above)
• Excellent time management skills with an ability to work on tight timelines;
• An ability to interact well within a team environment, but also work independently and manage own workload;
• Proficient in Microsoft Office and demonstrated ability to efficiently use safety database;
• Strong attention to detail;
• Demonstrate comprehensive knowledge of Japan Good Clinical Practice (GCP) guideline (including awareness of literature review and ‘measures taken processing’)
• Bilingual in Japanese and English
• Desired: Previous experience working with a Japanese Safety Database (e.g. Argus-J)

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 4,500 people across almost 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 paths
• Company-sponsored social and wellness events
• Official Sponsor of FC Cincinnati
• Hybrid work-from-home options and flexible work schedule
• On-site Market Place
• Free and covered parking
• Discounts for local businesses
• On campus restaurants and banks coming soon

Awards:

• 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
• Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What 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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