Patient Safety Associate
Roles & Responsibilities:
Manage collection, processing, documentation, reporting and follow-up of all adverse event (AE) reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
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
Experience/Skill: Knowledge of national and international regulations for pharmacovigilance, knowledge of pharmacological and medical terminology and excellent communications, interpersonal and negotiation skills
At least 1 year(s) of working experience in the related field is required for this position.
Preferably Junior Executives specializing in Healthcare - Pharmacy or equivalent.
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