Overview
Patient Safety Associate is mainly responsible for safety report management and other activities assigned. This role should understand company’s code of conducts & compliances policies & China & global PV Regulations, and manage the daily Pharmacovigilance( PV) activity to align with these accordingly.
This role is for upcoming future opportunities that may arise at Fortrea
Duties & Responsibilities
Key Result Areas - Safety report management
61 Maintain and receive safety report from all in-take channels
61 Handle safety report from all sources (clinical studies, spontaneous,
literatures, NMPA, etc), including:
- Data review, coding, translation and communication
- Report to global Data entry site
- Report to Health Authorities
- Query answering
- Tracking and archiving
- Late case communication and complete CAPA
61 QC peers and/or vendor’s case
61 Support team members and provide training to new staff
Other
61 Support or perform any other task that management deems appropriate.
Job Requirements
Academic / Professional Qualification
61 Master's degree in medical, pharmacy or other relevant majors
Technical / Skills Training
61 Familiar with PV laws and regulations, ensure the quality of various PV surveillance work
61 Familiar with GCP
61 Good organizational skills with the ability to multi-task and prioritize assignments (planning and organizing)
61 Good verbal and written communication skills
61 Good project management and problem solving skills
61 Proficient in common office software and office equipment operation skills
Working Experience
61 At least 0-1 year working experience in Pharmacovigilance