Senior Associate, Pharmacovigilance - Japan

• Author Safety Management Plans for assigned studies
• Attend internal and client meetings as appropriate
• Attend and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and track incoming safety information
• Generate queries for missing or unclear information and follow up with sites for resolution
• Perform quality control of SAEs processed by other Pharmacovigilance Associates
• Generate regulatory reports and perform safety submissions as needed
• Prepare and submit periodic safety reports as needed
• Maintain knowledge of safety-related regulations and guidelines
• Maintain basic understanding of project budgets and scopes of work, ensuring compliance and escalating potential scope changes
• Assist with bid defenses or other presentations as needed
• Mentor or train new Pharmacovigilance staff as needed
• Perform other duties as assigned

• Bachelor’s degree in a science-related field, or nursing, or equivalent
• Minimum of 5 years of pharmacovigilance experience in pre-approval clinical trials
• Equivalent combination of relevant education and experience
• Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word)
• Excellent understanding of medical and scientific terminology
• Understanding of clinical assessment principles for adverse drug events
• Understanding of international regulations and reporting requirements
• Understanding of relational database systems, including data extraction
• Excellent written and verbal communication skills
• Ability to work independently, prioritize work effectively, and work successfully in a matrix team environment
• Ability and willingness for potential limited domestic and international travel as needed
• Fluent in written and verbal English

• Diverse and inclusive work environment
• Collaboration and creativity-focused workplace
• Potential limited domestic and international travel