Senior Associate, Pharmacovigilance

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

📋 Description

• Develop the Safety Management Plan for designated studies.

• Participate in internal and client meetings as required.

• Attend and deliver presentations at Investigator Meetings.

• Examine incoming Serious Adverse Event (SAE) data for completeness and precision.

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

• Create queries for any missing or ambiguous information and follow up with sites to resolve issues.

• Perform quality control on SAEs processed by other Pharmacovigilance Associates.

• Produce regulatory reports and handle safety submissions as necessary.

• Prepare and send periodic safety reports as required.

• Stay informed about safety-related regulations and guidelines.

• Maintain a fundamental understanding of the budget and scope of work for assigned projects, ensuring compliance and addressing any potential scope changes.

• May assist with bid defenses or other presentations.

• May mentor or train new Pharmacovigilance staff.

• Execute other assigned responsibilities.

⛳️ Requirements

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

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

• Proficient in computer usage with a strong command of MS Office applications (Excel, PowerPoint, Word).

• Exceptional written and verbal communication abilities.

• Capability to work independently, effectively prioritize tasks, and thrive in a matrix team environment.

• Willingness to undertake potential limited travel (domestic and international) as necessary (to attend Investigator Meetings, project kick-off meetings, and/or bid defense meetings).

• Fluent in both written and spoken English.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible working hours.

• Paid time off.

• Opportunities for professional development.