Lead complex safety/endpoint projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products
Job Summary
Lead complex safety/endpoint projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products.
Work independently to perform day-to-day CEC activities through expert knowledge of specialty committee processes and procedures, and review adjudication publications to stay updated on current regulations.
Assist with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to specialty committee activities.
Matching Summary
Lead complex safety/endpoint projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices, contributing to the safety and efficacy of our products.
Skills & Requirements
Must-have
complex safety/endpoint projects
pharmacovigilance practices
CEC study start-up activities
electronic adjudication system build
expert knowledge of specialty committee processes
review adjudication publications
maintain medical understanding of therapeutic areas
prepare and QC CEC dossier compilation
routine project implementation and coordination
presentations at client/investigator meetings
departmental and project-specific procedures
attend audits and meetings
critical thinking and problem-solving skills
oral and written communication skills
work within multiple databases
compliance with procedural documents and regulations
manage and prioritize tasks
meet strict deadlines
limited supervision
strong attention to detail
positive and professional demeanor
work effectively within a team
Nice-to-have
global team collaboration
assist in preparation of procedures
maintain a positive demeanor in challenging circumstances