[Remote] Product Safety Coordinator

Note: The job is a remote job and is open to candidates in USA. Scalence L.L.C. is seeking a Product Safety Coordinator to manage the receipt and evaluation of adverse event reports for marketed and investigational products. The role involves case preparation, prioritizing workload to meet deadlines, and communication with partners and affiliates to ensure report accuracy.

Responsibilities

• 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

Skills

• 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
• 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
• Prior work experience in Product Safety/Pharmacovigilance

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