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Medical Monitor – Gastroenterology (Taipei)

PSI CRO · Taipei

🇬🇧 English
Pharmacovigilance

Job description

About the role

Join PSI’s Medical Monitoring team in Taipei as a Medical Monitor specializing in gastroenterology. You will work with an international group of medical professionals to ensure the safety and scientific integrity of clinical studies, helping bring new therapies to patients.

Key responsibilities

  • Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
  • Collaborate on clinical development plans, protocols, investigator brochures, reports and scientific presentations.
  • Review and analyse clinical data to safeguard study participants and ensure protocol compliance.
  • Address safety issues, participate in bid defenses and support pharmacovigilance activities.
  • Identify program risks and implement mitigation strategies with Clinical Operations.
  • Organise and lead advisory boards and safety monitoring boards.
  • Ensure compliance with local regulatory agencies, ICH and GCP guidelines.
  • Review and sign off clinical documents for medical relevance.

Required profile

  • Medical Doctor degree.
  • Board‑certification in gastroenterology preferred.
  • Clinical experience in major therapeutic areas such as oncology, infectious disease, gastroenterology, hematology or internal medicine.
  • Prior experience in clinical research and familiarity with local health‑authority interactions.
  • Ability to train and interact with clinical monitors and physician investigators.
  • Strong interpersonal skills to build constructive relationships at all organizational levels.

Required skills

  • Pharmacovigilance

Questions fréquentes

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Published 2 months ago

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PSI CRO

Taipei