Drug Safety Associate

The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

• 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

• 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

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.