What are the responsibilities and job description for the Product Safety Coordinator position at Zenith LifeScience, LLC?
Product Safety Coordinator
Location: 100% remote
Duration: 12 Months
Shift Timings: Mon-Fri (7.5 hours/day).
Job Description :
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, Company affiliate offices, and others as requested.
Requirements:
Location: 100% remote
Duration: 12 Months
Shift Timings: Mon-Fri (7.5 hours/day).
Job Description :
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, Company 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
