シニアマネージャー PV/ Senior Manager PV

A global biotechnology research company is seeking a Senior Manager PV. The selected candidate will oversee safety operations, lead teams, and ensure high-quality pharmacovigilance delivery.

Responsibilities:

• Lead and manage PSS staff, including performance oversight and resource allocation
• Oversee end-to-end PSS operations covering adverse event processes across clinical and post-marketing settings
• Manage expedited safety reporting and ensure timely submissions to clients and regulatory bodies
• Support team members in delivering safety services as part of project groups or standalone work
• Maintain service quality for internal and external clients while ensuring cost-efficient operations
• Ensure compliance with health, safety, and regulatory standards (Health and Safety at Work Act, COSHH, EC directives)

Requirements:

• Bachelor’s degree or above in life science or healthcare
• Experience in vendor management & oversight
• Prior experience with local safety database configuration & migration
• Proven experience in proposal development & budgeting, strategic client engagement, market intelligence & positioning
• Understanding of medical and drug terminology
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
• Familiarity with worldwide regulatory requirements and reporting of adverse event for both marketed and investigational product
• Prior knowledge of ICH guidelines
• Prior understanding of regulatory environment regarding Risk Management and Pharmacovigilance
• Prior Japanese GCP and GVP regulations knowledge
• Fluent level reading, written, and spoken Japanese and English

About the Company:

A company specialising in a wide range of services and solutions in the healthcare and diagnostics industry. They provide innovative technologies, diagnostic testing, and data-driven insights to support medical professionals and improve patient outcomes.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: PB2338