概述

• 薪资

  4,000 MYR ~ 7,000 MYR

• 产业类别

  Medical & Healthcare, Manufacturing(Pharmaceutical/Medical Equipment)

• 工作内容

  • Maintains current knowledge, ensures compliance, and communicates with the relevant global, regional and local functions of the local regulatory requirements.
  • Review, process and forwards safety events (pre-marketing and post-marketing) and/or other medically related information to Global PV and submits such safety events to the local health authority according to relevant global/local SOPs and local requirements.
  • Perform review of abstracts and full articles to identify safety information from literature source.
  • Support creation, management, and oversight of local RMP and all RMP-related PV activities.
  • Support creation and management of local PSMF development.
  • Liaise with investigational site and reporter as necessary regarding safety issues.
  • Develop local PV training material and conduct PV training as per relevant SOPs.
  • Prepare, review, update and maintain PV clauses in all relevant agreements from PV perspective.
  • Manages and conducts oversight of Aggregate Report submission to the applicable local health authorities.
  • Perform reconciliation of safety information with relevant internal and external functions.
  • Supports audits and inspections, including external vendors and ensures execution of deviation and CAPA management.
  • Develop and maintain PV Business Continuity Plan in accordance with global SOPs
  • Review and ensure that the local PV system file and related SOPs are up to date.
  • Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in the local market.
  • Reviewing change requests and assess regulatory impact of product changes
  • Reviewing proposed labelling for compliance with product branding, global/regional standards and applicable regulations
  • Prepare, maintain, and supervise implementation, including training of current applicable local, regional, and global SOPs to ensure compliance in the company as required.
  • Responsible for local GDP operational quality matters including product release, product hold and product recalls.
  • Support or lead the local GDP inspections from MOH and perform GDP self-inspection.
  • Support in addressing deviations, product complaints from customer to manufacturer, monitor the status until closure.
  • Manage outsourced activities to ensure vendors meet the applicable local and global standards including auditing vendors.