PVセーフティコントロールマネージャー/ Safety Control Manager in PV

A global life sciences company is seeking a Safety Control Manager in Pharmacovigilance. The selected candidate will oversee Japan-specific PV operations, ensuring compliance with regulatory standards and maintaining drug safety across product lifecycles.

Responsibilities:

• Develop and maintain PV System Master File and ensure compliance with Japan GVP requirements
• Ensure PV activities meet PMDA regulatory standards and liaise with authorities during inspections and audits
• Collect, evaluate, convert, and submit ICSRs to PMDA
• Conduct literature screening, evaluate findings, and submit valid reports to PMDA
• Author, review, and submit aggregate safety reports such as DSUR and PSUR
• Support Risk Management Plans for registered, marketed, or clinical-stage products
• Lead signal detection, assessment, and mitigation activities
• Conduct Foreign Measures Taken search, evaluate findings, and report to PMDA
• Oversee EPPV activities and develop PMS plans
• Support implementation and maintenance of Japan-specific safety databases
• Lead audit readiness, manage inspections, and implement CAPAs
• Manage and mentor a PV team while ensuring ongoing education and compliance
• Drive improvements in PV operations and ensure adaptation to regulatory changes
• Prepare proposals by estimating effort hours and timelines for client requests
• Act as subject matter expert on Japan PV and respond to client inquiries

Requirements:

• Bachelor’s degree or above in pharmacy, life sciences, or related field
• 4–7 years of pharmacovigilance experience
• Proven experience in Japanese PV regulations, including PMDA and GVP
• Skilled in global PV regulations (ICH; FDA and EMA knowledge is a plus)
• More than 3 years of safety management experience
• Ability to provide regulatory consultation for pharmaceutical clinical development is advantageous
• Proficient in safety databases and reporting tools
• Ability and willingness to travel
• Possess a valid Pharmacist licence is an advantage
• Proficient in written and verbal Japanese and English

About the Company:

A leading global provider of regulatory solutions, this life sciences company empowers pharmaceutical, biotech, and medical device firms to accelerate compliance across markets. Known for its deep domain expertise and end-to-end services, it supports clients in navigating complex regulatory landscapes with speed and precision.

Keywords:

ファーマコビジランス, 安全管理責任者, 有害事象報告, 文献スクリーニング, 安全性定期報告, リスク管理計画, シグナル検出, 医薬品安全性, 規制対応, 求人, 外資系

Job Ref: DOEPUC