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• 16 Oct 2024

  Sr Associate / Manager, Patient Safety (12mth contract)

  Taiwan Region

  Contract Position

  This company is a globally leading biopharmaceutical enterprise, focused on the research and manufacturing of drugs targeting various viral diseases. They have achieved significant results in the treatment of HIV/AIDS, Hepatitis C, and recently COVID-19, among other diseases. The company is committed to innovative medical solutions and promotes improvements in public health worldwide. Additionally, they are actively involved in the research and development of anti-cancer drugs and other therapeutic areas to meet the ever-changing medical needs.
  Job Description

  Key Responsibilities:

  Regulatory Compliance: Ensure all PV activities in Taiwan comply with local and global regulations, including Good Pharmacovigilance Practices (GVP).

  Communication: Effectively communicate changes in local regulations and safety concerns to the global Patient Safety team and relevant local stakeholders.

  Safety Oversight: Maintain expert knowledge of the safety profile of products marketed in Taiwan, ensuring prompt identification and management of emerging safety concerns.

  Risk Management: Collaborate on local Risk Management Plans (RMPs), providing input and ensuring alignment with global safety standards.

  Regulatory Authority Liaison: Serve as the primary point of contact with Taiwan’s regulatory authorities for safety-related queries, inspections, and documents, including RMPs and safety signals.

  Safety Reports: Oversee the reporting of Individual Case Safety Reports (ICSRs), ensuring timely submission and archiving in compliance with both company and national requirements.

  Training & Development: Provide ongoing training to staff and vendors on safety reporting procedures, ensuring all training is properly documented.

  Additional Responsibilities:

  Audits & Compliance: Support internal PV audits and regularly review global compliance reports to ensure corrective actions are taken when necessary.

  Expires on 16 Dec 2024

  Posted By

  Boris Ho

  Tel: (+886) 0922677776

  borisyp.ho@peoplesearch.jobs

  apply now

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  Requirements

  To thrive in this role, you should have the following qualifications and experience:

  Educational Background: A scientific or medical-scientific university degree in Life Sciences, Pharmacy, or a related field is required.

  Drug Safety Expertise: experience in pharmacovigilance or related field is an advantage, particularly in the post-marketing environment, with a comprehensive understanding of global and local safety regulations in Taiwan.

  Communication Skills: Strong written and oral communication abilities in English and Chinese, ensuring clear, concise, and business-appropriate messaging.

  Attention to Detail: Meticulous attention to detail with a demonstrated ability to produce high-quality work consistently.