Job Description

Join our global team and make an impact on patient safety worldwide!

About Us

At PrimeVigilance (part of the Ergomed Group), we are passionate about making a difference in patients' lives by delivering world-class pharmacovigilance services to our pharmaceutical and biotechnology partners. Since 2008, we’ve grown into a global leader with a presence across Europe, North America, and Asia.

We support diverse clients of all sizes and therapeutic areas—including medical devices—and we pride ourselves on long-lasting partnerships built on trust, quality, and integrity.

As a people-first organization, we offer an inclusive, flexible, and supportive work environment where your career can thrive —no matter where you’re based.

Job Description

The Role:

We’re looking for a highly skilled pharmacovigilance professional with fluency in both Japanese and English, who is passionate about patient safety and thrives in a collaborative, cross-cultural environment.

As a Senior PV Officer, you’ll take ownership of case processing services, ensuring timely and accurate reporting in compliance with global regulatory requirements. You’ll play a pivotal role in maintaining drug and device safety—and ultimately improving patient outcomes.

What You’ll Be Doing

• Independently process Individual Case Safety Reports (ICSRs) from various sources, including post-marketing and clinical trials
• Manage SAE/SUSAR submissions, unblinding activities, and clinical trial reconciliations
• Support the preparation of database outputs for PBRER, DSUR, PADER, and other regulatory reports
• Mentor and train junior team members, contributing to continuous improvement of processes
• Ensure full compliance with global regulatory requirements, client expectations, and internal quality standards

Qualifications

What We’re Looking For

• Fluency in Japanese and English , both written and spoken
• Degree in Life Sciences, Biomedical, or a related healthcare field (e.g., Chemistry, Biology, Biotechnology, Veterinary Science)
• Proven pharmacovigilance case processing experience
• Experience with ARGUS safety database (preferred)
• Strong attention to detail, organization, and multitasking abilities
• A collaborative mindset and excellent communication skills

Additional Information

Why You’ll Love Working with Us

• Hybrid remote role in Tokyo with flexible working hours
• A supportive, inclusive, and global team
• Comprehensive training and career development opportunities
• Exposure to diverse projects across multiple therapy areas
• A company culture centered around trust, respect, and belonging
• Clear pathways for professional growth and leadership opportunities

Our Values

We live by six core values that guide everything we do:

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Ready to Join Us?

If you’re a passionate pharmacovigilance professional ready to make a global impact, we’d love to hear from you!

Apply today and be part of a team that’s making healthcare safer for patients worldwide.

PrimeVigilance is an Equal Opportunity Employer

We’re committed to diversity, equity, and inclusion and encourage applications from all backgrounds, cultures, and experiences

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