Pharmacovigilance Director

Job Title: Director of Pharmacovigilance

Location: Tokyo, Japan

Reporting To: Global Head of Pharmacovigilance

Company Overview:

Our Client is a pioneering American pharmaceutical company specializing in the development of innovative therapies for rare diseases. Committed to making a difference in the lives of patients with unmet medical needs, we are at the forefront of scientific and medical advancements. We are seeking a highly skilled and experienced Director of Pharmacovigilance to join our global team and lead our pharmacovigilance efforts in Tokyo.

Position Overview:

As the Director of Pharmacovigilance, you will be responsible for overseeing and managing all aspects of pharmacovigilance activities in Japan. Reporting directly to the Global Head of Pharmacovigilance, you will play a crucial role in ensuring the safety and well-being of patients receiving our therapies. This position requires a strong understanding of global pharmacovigilance regulations, excellent leadership skills, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities:

Leadership and Team Management:

Provide leadership and guidance to the pharmacovigilance team in Tokyo, fostering a culture of excellence and collaboration.

Develop and mentor team members, ensuring continuous professional development.

Local Pharmacovigilance Operations:

Oversee the planning and execution of pharmacovigilance activities in Japan, ensuring compliance with local regulations and global standards.

Collaborate with global counterparts to align processes and share best practices.

Safety Surveillance and Signal Detection:

Implement and manage safety surveillance processes for marketed products and investigational compounds.

Lead signal detection activities and contribute to the development of risk management strategies.

Regulatory Compliance:

Ensure compliance with Japanese pharmacovigilance regulations and guidelines.

Collaborate with regulatory affairs to support submissions and responses related to safety matters.

Case Management and Reporting:

Oversee the timely and accurate processing of adverse event reports and ensure submission to regulatory authorities as required.

Review and contribute to the preparation of aggregate safety reports.

Cross-Functional Collaboration:

Work closely with other departments, including clinical development, regulatory affairs, and medical affairs, to integrate pharmacovigilance activities into overall drug development plans.

Qualifications:

Advanced degree in pharmacy, life sciences, or a related field.

In-depth knowledge of Japanese pharmacovigilance regulations and guidelines.

Strong understanding of global pharmacovigilance best practices.

Excellent communication and interpersonal skills.

Ability to lead and influence cross-functional teams.