Pharmacovigilance Offres d'emploi - Ladner, BC

PSI Medical Monitors  provide medical input to global clinical studies and advise the teams and business partners while always focusing on patients safety and wellbeing.

HomeBased in Canada

Responsibilities :

• Advise clients project teams sites data safety monitoring boards regulatory agencies and thirdparty 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
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA EMEA ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance.

Qualifications :

Additional Information :

As part of PSIs 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.

Remote Work : Employment Type :

Fulltime

Key Skills

Time Management,Diplomatic Skills,Risk Management,Influencing Skills,Organizational Skill,Accounting & Finance,Strategy Management,People Management,Industril Knowledge,Communication,Negotiation Skills,Strategic Thinking Skills,Leadership Skill,Problem Solving Skills,Regulatory&Governance

Vacancy : 1