Product Safety Coordinator

Job Description

Duties and 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, client affiliate offices, and others as requested.

Education and Experience:

• Only BS, Pharm D is acceptable.
• Bachelors degree required, preferably in a scientific or medical discipline.
• Looking for less than 7 years experience.
• Previous experience in data coding and retrieval skills using database technology.
• Prior work experience in Product Safety/Pharmacovigilance preferred.

Knowledge, Skills and Abilities:

• 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.