PRIMARY FUNCTION:
The position is responsible to provide medical expertise and medically review of AE/SAE information received from sites for completeness and regulatory compliance.

MAJOR RESPONSIBILITIES:
? Review adverse event reports received from sites/reporters.
? Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
? Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.
? Liaise with the medical reviewers/client in other regions to agree upon the queries to request for additional information to the sites/reporter.
? Ensure case files are compliant with SOPs.
? Ensure compliance with company policies, procedures, and standards.
? Participate in audits as required/appropriate.
? Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects.
? Mentor or train less experienced Safety Associates on processes regarding case management.
? Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
? Any other duties as assigned by manger.

Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

EDUCATION REQUIRED:
? Bachelors Degree in medicine or equivalent combination of education and experience

MINIMUM TRAINING & EXPERIENCE REQUIRED:
? Familiarity with safety database systems: ARISg or Argus preferred
? Ability to successfully prioritize and work on multiple tasks
? Excellent team player and attention to detail
? Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
? Excellent knowledge of ICH guidelines and regulations relating to safety reporting.
? Computer proficient including experience with Microsoft Office Suite, including but not limited to word processing software (MS Word), presentation software (MS Powerpoint), email software (Outlook), diagramming/workflow software (MS Visio), and spreadsheet software (MS Excel)
? Ability to travel as necessary (less than 5%).

上班地址：汇贤园