概述

• 薪资

  3,800 MYR ~ 4,500 MYR

• 产业类别

  Manufacturing(Pharmaceutical/Medical Equipment)

• 工作内容

  Roles & Responsibilities:
  Pharmacovigilance
  • 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.
  • 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.
  
  Regulatory
  • Support the preparation and archival of 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.
  • Provide regulatory intelligence and input, and support the development and implementation of local regulatory strategies.
  • Maintain local label database
  
  Quality Management/Quality Assurance
  • Support the local GDP inspections from health authority and perform GDP self-inspection.
  • Support in addressing deviations, product complaints from customer to manufacturer, monitor the status until closure.
  • Support in updating SOP and maintaining records in accordance with Good Distribution Practice or any other relevant regulations/guidelines.
  • Support in product imports, redressing and release to local markets.
  • Manage outsourced activities to ensure vendors meet the applicable local and global standards, including auditing vendors.
  • Review and manage promotional materials.