What You Will Do

• Author Safety Management Plan for assigned studies
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• Generate queries for missing or unclear information and follow-up with sites for resolution
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and perform safety submissions as needed
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What You Will Bring To The Role

• Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
• Good understanding of computer technology, and management of relational database systems, including extraction of data
• Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
• Excellent organization skills and ability to handle multiple competing priorities within tight timelines
• Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities
• Ability to anticipate needs and follow through on all assigned tasks
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Your Experience