Contribute to global medicine safety as a specialist in pharmacovigilance focusing on high quality pharmaceutical research and development activities for an international organization. Apply foundational experience in safety data handling and clinical documentation to support compliant case management and timely reporting. Work in a hybrid day shift model collaborating with cross functional teams to protect patient wellbeing and strengthen public trust in healthcare innovations.
Responsibilities
Perform end to end pharmacovigilance case handling activities for assigned safety reports ensuring accurate data capture narrative clarity and consistent application of internal procedures to support reliable patient safety decisions.
Review source documents and clinical data from pharmaceutical research and development activities validate medical information and identify relevant safety details that contribute to robust evaluation of product risk and benefit profiles.
Execute standardized workflows for spontaneous and solicited adverse event intake classification and data entry maintaining high levels of data quality and compliance with global pharmacovigilance regulations and company governance.
Conduct detailed medical assessment of individual case safety reports within scope of experience confirm event seriousness and expectedness and escalate complex or medically sensitive cases to senior safety reviewers as needed.
Prepare regulatory compliant individual case safety report outputs including medically coherent narratives and structured data elements to enable timely electronic submission to health authorities and business partners.
Support the maintenance of case processing metrics by monitoring workload queues prioritizing urgent regulatory timelines and collaborating with colleagues so that safety reports are completed within agreed service levels.
Apply knowledge of pharmaceutical research and development processes to contextualize reported adverse eve