Total 2 Health / Beauty / Fitness job vacancies in Tokyo

PrimeVigilance is looking for a Medical Information Associate to be responsible for supporting the Medical Information team in handling initial adverse event and medical information inquiries in English.  

Responsibilities 

• To provide approved responses to medical enquiries (healthcare professionals, patients, pharmaceutical clients) including call handling  
• To accurately identify, document and report adverse events/side effects, pregnancy and other special situation events, and product quality complaints within required timeframes 
• To ensure that all medical information enquiries are tracked and fully documented within the Medical Information database accurately and completely 
• To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 enquiry handling service 
•  Providing management with regular updates regarding project status and metrics concerning enquiries 
• Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits;  

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Office location: Tokyo or Osaka 

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organise and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance