Senior Pharmacovigilance Associate – Japan (Remote)

Worldwide Clinical Trials; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Worldwide Clinical Trials is seeking a pharmacovigilance professional with 5+ years of pre‑approval PV experience to support safety data management and regulatory submissions. You will review SAE data, maintain safety databases, and generate safety reports while coordinating with global teams.

The role requires strong MS Office skills, excellent communication, and the ability to work independently within a matrix environment.

Qualifications

• Bachelor’s degree in a science-related field, or nursing, or equivalent.
• A minimum of 5 years of pharmacovigilance experience (pre‑approval clinical trials).
• Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word).
• Excellent written and verbal communication skills.
• Fluent in written and verbal English.

Responsibilities

• Author Safety Management Plan 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/or 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
• Prepare and submit periodic safety reports as needed

Skills

Pharmacovigilance knowledge

Safety data management

Medical terminology

MS Office proficiency

Communication skills

Team coordination

Education

Bachelor's degree in science or nursing

Tools

Relational databases

Safety database software

Job description

Worldwide Clinical Trials is seeking a pharmacovigilance professional with 5+ years of pre‑approval PV experience to support safety data management and regulatory submissions. You will review SAE data, maintain safety databases, and generate safety reports while coordinating with global teams.

The role requires strong MS Office skills, excellent communication, and the ability to work independently within a matrix environment.