ASK Resources is looking for new potential candidates to fill in for Patient Safety Associate - MNC | China Market (Salary up to RM6000) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Top MNC: Science-based Healthcare Company (Pharmaceutical)
- Good Explosures & Oustanding Opportunity
- Normal Working Hour @ 8am - 5pm
- Manage collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports for all company products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports.
- Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities (LHA) and/or clinical operations in cooperation with other departments.
- Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
- Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
- Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
- Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
- Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
- Management and maintenance of all relevant Patient Safety databases.
- Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
- Develop and update training materials for pharmacovigilance and ensure training of associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
- Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
- Ensure training and oversight of staff, as applicable.
- Manage and maintain efficient Patient Safety filing and archive system.
- Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree in Medicine, Nursing, Pharmacy/Pharmacology or equivalent.
- Required language(s): English, Bahasa Malaysia & Mandarin (China Market)
- Knowledge of national and international regulations for pharmacovigilance & knowledge of pharmacological and medical terminology
- At least 1 year(s) of working experience in the related field is required for this position.
- Basic Salary up to RM6000
- EPF, Socso, EIS, annual leave & etc.
- One-year Contract
***Only shortlisted candidate will be notified again. Thanks.
How To Apply
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