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Medical Sciences Opportunities at Parexel

Medical Sciences

Team Manager

Job ID 54347BR Shenyang Wobu, Liaoning, China
Job Purpose:
Team Manager, Safety Operations will line manage and supervise regional Drug Safety staff on a day-to-day basis, guiding performance of Drug Safety staff in ongoing projects in terms of quality of deliverables and compliance with the budget, as well as providing their own technical and process-related expertise to drug safety management (clinical trial and postmarketed)
and medical monitoring activities, ensuring compliance with relevant regulations and
Standard Operating Procedures (SOPs).

Responsibilities:
Delegate work to staff according to allocated budget/hours
Assess staffing needs for projects
Support recruitment
Organize, mentoring and training for new staff
Develop project specific safety procedures, workflows and templates
Perform project specific safety database setup, develop data entry guidelines, and perform user acceptance testing
Organization and coordination of study specific workflows with regard to processing and reporting of
Serious Adverse Events (SAEs)
Perform Quality control of case reports, line listings, and tabulations

Qualifications

Skills:
• Excellent leadership and line management skills
• Excellent knowledge of drug safety and the drug development process
• Excellent knowledge of and ability to interpret and apply global safety regulations
• Experience in data analysis, evaluation of safety data and the preparation of safety reports
• Excellent team / project leadership and delegation skills
• Ability to train and mentor people
• Excellent presentation skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent time management skills
• Client focused approach to work
• Experience with computer applications including database management and
Pharmacovigilance related computing systems

Knowledge and Experience:
• Considerable drug safety knowledge and experience
• Experience in working in drug development and/or healthcare environment

Education:
• Degree in Pharmacy, Nursing, Life Science, or other health-related field , or
equivalent qualification
• Associates/diploma degree in any of the above with appropriate work experience

Language:
• Japanese
• English

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