Job Description

Company Overview
Global Pharma Maker

Job Description
• Provide leadership and management of Japan PV group, ensuring timely and appropriate service levels and compliance with Clinigen Group’s contractual and regulatory obligations
• Responsible for the establishment and maintenance of the PV system(s), acting to fulfil responsibilities as a Marketing Authorizsation Holder (MAH)
• Support global PV to ensure that they can meet their regulatory obligations
• Influence the performance of Japan’s GQP as it relates to pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements of Pharmacovigilance
• Ensure the information contained in Japan’s GVP is an accurate and up-to-date reflection of the pharmacovigilance system
• Maintain oversight of and ensure Japan and global Pharmacovigilance regulatory compliance
• Oversee and enable the addition of new products into the Pharmacovigilance System, in collaboration with and after approval of the global PV for such admissions
• Ensure appropriate management of Safety Data Exchange Agreements (SDEA) with global PV
• In collaboration with Quality, ensure the creation, maintenance and operation of the PV System Audit plan
• Approve Risk Management Plans, PMS plan and report, Aggregate Reports (e.g. Periodic Safety Update Report), GPV SOP, and other key PV regulatory documents
• Oversees and ensures compliance with the companies post-marketing PV regulatory commitments

• Extensive (5-10 years) experience of Pharmacovigilance in the Pharmaceutical or service Industry
• Scientific or medical degree
• Experience in Line Management
• Leadership skills, ability to coach and develop others and to act as a catalyst for positive change
• Demonstrated ability to influence
• Experience in unlicensed medication a plus
• Fluent in written and spoken English with strong verbal and written communication skills
• Experience in developing SOPs, RMPs and other PV documents
• Expert knowledge of Japan and global pharmacovigilance regulations and guidance
• Ability to travel