Manager, Safety Surveillance

Japan
Full Time
Posted
2 weeks ago

MAIN RESPONSIBILITIES

• Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.

• Implement quality assurance regulations.

• Write and revise standard operating procedures.

• Support and facilitate audits and regulatory inspections.

• Support Quality Assurance Manager in supervision of all quality control aspects of the process (laboratories studies, clinical research, testing, operations).

• Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.

• Lead implementation of new regulations.

• May support quality training.