Receipt and triage of adverse event reports for marketed and investigational products from all sources.
Preliminary evaluation of clinical trial, spontaneous (post-marketing), and solicited reports of adverse events, including communication with partners and affiliates when necessary to verify completeness and accuracy.
Case preparation - duplicate searches, initial data entry, and assignment of cases to Specialists.
Particular emphasis is placed on determination of seriousness, expectedness, and validity.
Prioritizes workload to ensure Company and Regulatory Authority deadlines are met.
May include internal and external distribution of information to co-marketing partners, affiliate offices, and others as requested.
Requirements
Bachelor’s degree required, preferably in a scientific or medical discipline
Previous experience in data coding and retrieval skills using database technology
Knowledge of medical terminology
Prior work experience in Product Safety/Pharmacovigilance preferred
Precise attention to detail and ability to multi-task
Good communication skills, both written and verbal
Ability to work independently, and as part of a team
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Staffing and Recruiting
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