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Medical Sciences Opportunities at Parexel

Medical Sciences

Drug Safety Specialist

Job ID 55415BR Shenyang Wobu, Liaoning, China
Quality control of case reports, line listings, and tabulations
Perform literature searches
Develop Expedited Reporting Procedures
Maintain local drug safety reporting requirements
Provide advice in regulatory affairs
Perform registration with relevant authorities for electronic reporting on behalf of sponsor
Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local
ECs, and investigator sites (electronic and hard copy)
Submission of periodic safety reports (i.e. DSUR, ASR)
Submission of safety reports to investigators via ISIS (International Safety
Information System)
Measure investigative site performance in conducting required tasks in ISIS
Tracking and filing of submission cases as required
Unblinding of SUSARs, as required
Collect and review metrics for measuring reporting compliance
Work with Global PV Information Office for collection and organization of global PV requirements

Qualifications

Skills:
• Sound knowledge of drug safety and the drug development process
• Knowledge of and ability to interpret and apply global safety regulations
• Experience in data analysis and evaluation of safety data
• Good presentation skills
• Analytical and problem solving skills
• Clear understanding of the regulatory submission process
• Proficient in database/literature searches
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Experience with computer applications including database management and pharmacovigilance
systems

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

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