Job Summary :
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;
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Act as an internal and external advisor on safety related matters;
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Identify and manage process improvements, SOP updates and training initiatives;
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Manage various levels of employees; and
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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;
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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) 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
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Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
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Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
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Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
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Office based environment with on-site mentors
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Defined career paths with clear advancement opportunities
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Industry renowned onboarding and training programs designed to accelerate professional development
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Ongoing training and continuous learning opportunities throughout your career
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An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
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Competitive compensation programs that recognize and reward performance
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Comprehensive health, wellness, retirement, and PTO benefits
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Office based culture with occasional WFH that provides flexibility for eligible positions after training
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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.
