Safety And Regulatory Specialist

10 hours ago

Taipei Taipei City, Taiwan Avance Clinical Full time NT$900,000 - NT$1,200,000 per year

Company Description

Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across New Zealand, Asia, North America, and Europe. As market leaders in early phase clinical trials, we leverage the unique advantages of the Australian market to provide biotechs with an accelerated pathway to clinical success. Our focus on agility, innovation, and cost-effectiveness delivers fast, robust results that are globally accepted. With expertise spanning over 250+ indications across all therapeutic areas, we consistently provide data recognized by key global regulators. Our personalized service ensures customized, flexible solutions tailored to each client.

Role Description

This is a full-time on-site role for a Safety and Regulatory Specialist located in Taiwan. The Safety and Regulatory Specialist will be responsible for ensuring compliance with Taiwan regulatory requirements, supported by a global safety and regulatory team. Other responsibilities will include preparing Safety Management Plans, supporting Safety database set ups, DSUR preparation and suvmission ans expedited safety submissions. The position also includes the liaison with study sites for emerging safety matters where required, liaising with regulatory authorities, and overseeing safety incident investigations.

Qualifications

  • Experience in PV/Safety Reporting in clinical trials
  • Experience in preparing and submitting regulatory submissions, and liaising with regulatory authorities
  • Proficiency in developing and implementing safety Management Plans
  • Skills in monitoring and reporting safety data
  • Excellent written and verbal communication skills in local language and English
  • Ability to work independently and on-site in Taiwan when required
  • Experience in the pharmaceutical or clinical research industry is a plus
  • Relevant educational background in life sciences or related field

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