Salario en MEDICAGO

Requisitos

• physician with minimum 4 years related experience in clinical safety and pharmacovigilance
• experience in the vaccine therapeutic area is preferred
• experienced in global regulatory environment and processes, and the ability to integrate safety medical knowledge with regulatory and commercial input
  Mostrar más +8
• experienced in writing and reviewing PV documents and risk management plans
• thorough understanding of Canada, US, and EU pharmacovigilance regulations, GCP and ICH guidelines
• good ability to interpret complex clinical data and experimental results
• demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of product risks and benefits, and safety assessment of products and global safety regulations are highly preferred
• working knowledge of validated drug safety database and MedDRA
• ability to influence, negotiate and communicate with both internal and external stakeholders
• ability to critically evaluate safety data from multiple sources , assess clinical importance, benefit-risk and potential strategic impact of the data and present the findings clearly in both written and oral communications
• excellent English and excellent mastery of English medical terminology