Job Description
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Associate Director, Clinical Safety to join our Clinical Safety Department in Tokyo, Japan. This position plays a key role in the pharmacovigilance process at Medpace. If you want an exciting career where you use your previous nursing or pharmacovigilance expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Oversee clinical safety case management and aggregate reporting responsibilities at a
program level; - Maintain relationships with clients and internal stakeholders by providing expert safety
knowledge; - Provide safety review of clinical study documents, including protocols, study reports, and
marketing application components; - Identify and manage process improvements, SOP updates, and training initiatives;
- Act as an internal and external advisor on safety related matters;
- Identify and manage process improvements, SOP updates and training initiatives;
- Manage various levels of employees; and
- May be responsible for other projects and responsibilities as assigned.
Qualifications
- Master’s degree and 5 years of clinical safety experience or Bachelor’s degree and 8 years of
clinical safety experience; - Safety experience in a leadership position at a CRO;
- Responsible for departmental hiring, training, management, and evaluation of Clinical Safety
employees and other support personnel; - Directly manages other Clinical Safety Coordinators and Managers in development of safety
plans, Standard Operating Procedures, guidelines, and narratives, and - Bilingual Japanese and English.
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 6,000 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.