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Zuellig Pharma started almost a hundred years ago and has grown to become a US$ 13 billion business covering 13 markets with 13,000 employees. We serve over 350,000 medical facilities and work... Chi tiết

Mô tả Công việc

This role is to ensure that drugs on the market are safe for patients and identify/escalate any problem that can cause patient’s safety and drug profile issues.

  • Set-up, manage and implement Zuellig Pharmacovigilance System for all products of Zuellig.
  • Ensure product quality and patient safety, focus on business-critical issues that may have an impact on license to operate and inspection readiness.
  • Ensure that the Pharmacovigilance system is maintained and in compliance with local national, internal and external requirements
  • Ensure the training of PV to all Zuellig staffs and third-party vendors to compliance of Zuellig SOPs
  • Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry center or contractual partners
  • Conduct reconciliation of adverse events reports received from other company operating units and contractual partners, as applicable
  • Submit, as applicable, spontaneous and solicited / clinical trial individual case safety reports (ICSRs) from the country/territories to the local Health Authorities
  • File, store, and archive safety-related data
  • Serves as back-up coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity
  • Serves as the local Deputy Qualified Person for PV for their country
  • Comply with PV regulations and Global Safety policies/procedures and when needed take corrective action
  • Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
  • Prepare for audits/inspections for their country/territories and participates in the audit and/or inspection
  • Identify and communicate potential safety issues
  • Complete and document required PV training within required timelines
  • Serve as the point of contact for the local Health Authority or liaise with the Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in absence of the Pharmacovigilance Country Lead

  • Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensure processes are in place for activities that are performed by those functions which impact PV

  • Liaise with PV Regional Centers/Data Management Centers

Yêu Cầu Công Việc

  • Minimum with BS/BA degree or equivalent in Medical or Health Sciences e.g. Clinical Medicine, Pharmacy, Life Sciences, or Pharmacology.
  • Proven industry experience in pharmacovigilance.
  • Extensive knowledge of Pharmacovigilance regulations in their country/territory.
  • Strong scientific, and technical skills in Pharmacovigilance, and Medical Information
  • Strong verbal and written communication skills
  • Strong organizational and presentation skills
  • Strong interpersonal leadership skills
  • Ability to work independently and collaboratively within a team internally
  • Ability to engage customer relationship building skills
  • Management skills and ability to coach and development teams
  • Ability to use computers (MS Word, MS Excel, and MS PowerPoint) and related technology efficiently

Thông tin khác

  • Kinh nghiệm: 3 - 5 Năm
Thông Tin Tuyển Dụng

Pharmacovigilance Executive

Zuellig Pharma Viet Nam

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