Pharmacovigilance; PV Audit Manager; Consultant

• Contract

Entrepreneurial Spirit, Rooted in Tradition
. At Mitsubishi Tanabe Pharma Development America (MTDA), we have a storied reputation spanning over 300 years. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

Relatively new to the U.S. market, the Mitsubishi Tanabe Pharma Group's innovative compounds have already achieved commercial success under our U.S. partners' brands. We are now planning to bring new compounds to market under our own MT Pharma America label and are expanding our commercial organization and support functions.

We are seeking a dynamic individual to join our QA team as a part-time consultant to ensure quality across MTDA. The selected Consultant will support the Senior Director of QA in delivering an integrated PV QA program. Responsibilities include developing and maintaining the MTDA Quality system, including SOPs, audits, inspection prep, QA metrics, regulatory intelligence, process mapping, and computer validation. The consultant will collaborate with the QA Manager to ensure:

• Protection of Subjects
• Veracity of Data
• Legal Protection of the Company

This fixed-term 12-month consulting assignment offers a flexible 4-day per month schedule
.

Key responsibilities include:

• Supervising PV activities within MTDA under the Senior Director QA
• Managing workload to cover projects and activities
• Providing QA input to MTDA working groups and systems development
• Advising MTDA staff on QA and PV matters
• Liaising with Regulatory Affairs on ongoing regulatory changes
• Participating in internal and external meetings
• Arranging audits as per audit plans
• Performing internal process audits of MTDA processes
• Preparing audit reports within 30 days
• Distributing audit reports per MTDA policy
• Assisting in global activities and systems from MTPC
• Liaising with QA MTPC & MTPE on global programs
• Hosting PV audits and regulatory inspections of MTDA activities

Minimum qualifications:

• Bachelor's degree in a scientific discipline or related field
• At least 5 years of independent auditing experience
• Experience with at least 2 regulatory inspections, including one FDA PV inspection
• Membership in professional associations (e.g., DIA, SQA)
• Proficiency in MS Office
• CSV audit ability is a plus

Willing to travel approximately 50% domestically and internationally.

Our Value Proposition:

Experience the entrepreneurial spirit of a small biotech combined with the benefits of a global pharmaceutical company.