Senior Associate, Pharmacovigilance - Japan

🔥 0 minutes ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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