Senior Associate, Pharmacovigilance – Japan

This is a fully remote position, open to applicants in Japan.

📋 Description

• Create Safety Management Plans for designated studies.

• Participate in internal and client meetings as necessary.

• Attend and present at Investigator Meetings.

• Assess incoming Serious Adverse Event (SAE) data for completeness and accuracy.

• Conduct data entry in the Safety Database and/or monitor incoming safety information.

• Generate inquiries for missing or ambiguous information and follow up with sites for clarification.

• Execute quality control for SAEs processed by other Pharmacovigilance Associates.

• Produce regulatory reports and carry out safety submissions as required.

• Prepare and file periodic safety reports as necessary.

• Stay informed about safety-related regulations and guidelines.

• Maintain a fundamental understanding of project budgets and scopes of work, ensuring compliance and reporting potential scope changes.

• Assist in bid defenses or other presentation activities.

• Mentor or train new Pharmacovigilance team members.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in a science-related discipline or nursing, or equivalent.

• Equivalent combination of relevant education and experience.

• At least 5 years of pharmacovigilance experience in pre-approval clinical trials.

• Strong understanding of medical and scientific terminology.

• Knowledge of clinical assessment principles for adverse drug events.

• Familiarity with international regulations and reporting obligations.

• Proficient in computer technology and relational database systems, including data extraction.

• Computer literacy and a solid working knowledge of MS Office applications (Excel, PowerPoint, Word).

• Exceptional written and verbal communication skills.

• Ability to work independently and effectively prioritize tasks.

• Capacity to thrive in a matrix team environment.

• Willingness for potential limited domestic and international travel as required.

• Proficient in written and spoken English.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative teams.

• Accessible, hands-on leadership.

• Potential for limited domestic and international travel as required.