Regulatory Affairs:
Prepare, submit, and follow up registration dossier of the assigned products with MOH.
Prepare, submit, and follow up GMP assessment for all manufacturers and follow up with MOH
Build good relationships with health authorities experts for better work efficiency.
Cooperate with relevant departments (marketing, sales team) to prepare advertising documents.
Support and update necessary documents for tenders.
Update reports, and systems as required
Conduct the regulatory surveys, communicate with regional for assigned products
Other tasks assigned by the manager not limited to:
Keeping pace with regulatory requirements.
Ensure approval of registration applications of all medicines in applicable countries.
Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
Ensure compliance with quality requirements on release of medicine for sale in line with GMP and company policies and procedures.
Prepare and update data for MDR, MIMS or any other external product database for all marketed products in liaison with the Regulatory Affairs Head.
Establish and maintain effective relationships with all stakeholders
Pharmacovigilance:
Support the local safety officer regarding PV SOP and PV agreement, update local regulations about PV, assess the impact on local SOP, manage compliance with SOP and local regulations, signal detection, and risk management measures of oncology products.
Attend PV meetings and training from CSPV.
Collect ADR cases of assigned products from FF/Marketing/partners
Handle queries about safety information of assigned products, inform CSPV about updating safety information of assigned products, prepare PSUR reports and Form 2A of assigned products, and submit to the National ADR Center.
Literature search in local journals
Prepare PV quarterly report, PV training materials for assigned products, and support manager to conduct PV training, support Local Safety Officers to prepare for PV audit.
Requirement
Bachelors degree in Pharmacy or course related to the pharmaceutical field
At least 2 years experience in a similar position (Regulatory Affairs & Pharmacovigilance) in MNC companies
MS Office (Outlook, PowerPoint, Excel, and Word) proficiency.
Apply via :
www.careers-page.com
