Supports the implementation of local PV processes and tasks
Ensure compliance with all requirements mentioned in the local laws and regulations
Responsible for day-to-day adverse events case management
To coordinate translation of documents and ensure a QC check is performed
To organize, store, and archive safety-related and regulatory data and documents following departmental and company protocols as well as local regulations.
Supports local PV audits and inspections when requested
Participates in compliance efforts and facilitates the preparation of required corrective actions.
Responsible for managing and performing local literature screening and assessment
Responsible for Health Authority Website
Monitoring for potential safety issues safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation
Participate in special projects or rotational assignments
Performs other activities as requested by manager
Job Requirements:
Candidate must possess at least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor\xe2\x80\x99s Degree, Post Graduate Diploma, Professional Degree, Master\xe2\x80\x99s Degree BioMedical, Medical Science, Life Science or equivalent
1-2 year of working experience in pharmacovigilance related activities and safety with MNC Environment
Strong communications, organizational, and time management skills
Proficient in Microsoft Office applications especially Excel files
Confident, mature, resourceful with a pleasant personality and willingness to learn
Good communication skills with possess good oral and written skills. Proficiency in English is essential.
Others Information:For those who have what it takes, please send in resume to: Consultant: Janice Lim Email:Agensi Pekerjaan & Perundingcara Bright Prospect Sdn BhdNo, 18, 2nd Floor, Jalan 14/14, 46100 Petaling Jaya, Selangor Tel : +603-7954 8440Lot No.28-03, 28th Floor, Public Bank Tower, No.19, Jalan Wong Ah Fook, 80000 Johor Bahru, Johor. Tel : 607 -2233 228