Senior Pharmacovigilance Officer (Fluency Japanese required)- hybrid working
- Full-time
- Department: ICSR Management
Company 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