Overview Embark on an exciting journey as our Global Pharmacovigilance Data Specialist! As a pivotal member of our global pharmacovigilance team, you'll shine in the analysis and interpretation of intricate adverse event reports from a multitude of sources and therapeutic areas. Your expertise will be crucial in ensuring our investigational and marketed products meet stringent safety standards. In this dynamic role, you'll collaborate closely with both internal and external stakeholders to resolve complex issues and uphold process standardization. Your multilingual skills, particularly in English and a second language such as Portuguese and/or French, will be instrumental in translating critical adverse event reports. Responsibilities Performing analysis, interpretation, and data entry of adverse event reports from a wide range of sources and therapeutic areas, demonstrating increasing proficiency in clinical knowledge, processes, and regulatory guidelines. Providing support in written translation of adverse events reports from different countries. Collaborating with internal and external stakeholders to resolve issues of varying complexity to guarantee process standardization and adherence and ensure compliance with reporting requirements. Supporting simplification and optimization of case management activities to enhance overall effectiveness. Education and Other Qualifications Bachelor’s degree or above in health care or life sciences disciplines (Nurse, Veterinary, Pharmacist, Bacteriologist or Biologist/Microbiologist). English Advanced (C1) proficiency or Intermediate B2 with C1 level in writing and reading. A certificate or diploma verifying this level will be required. Upper Intermediate to Advanced proficiency in one of the following languages is required: Mainly Portuguese and desirable French. A certificate or diploma to confirm their proficiency level. At least one year of working experience is required. Clinical and/or Pharmacovigilance-related experience is desired. Required Skills Adaptability Bacteriology Case Management Clinical Data Cleaning Clinical Data Management Clinical Knowledge Collaborative Development Customer-Focused Data Analysis Database Development Data ProcessingData Quality Assurance Data Review Data Validation Data Visualization Electronic Data Capture (EDC) Learning Agility Microbiological Cultures Microbiology Multilingualism Pharmacovigilance PL/SQL (Programming Language) Process Standardization Regulatory Compliance Safety Standards About Our Company Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr
Global Pharmacovigilance Data Specialist - Trilingual
MSD MALAYSIA
Bogotá, Bogotá
Publicado hace 11 días
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