Pharmacovigilance Specialist

TL;DR

Pharmacovigilance Specialist: Contributing to and executing pharmacovigilance activities related to Individual Case Safety Report (ICSR) case processing of, aggregate reports such as J-PSUR, NUPR, J-DSUR and other pharmacovigilance deliverables with an accent on scientific content and alignment with company position, clarity, accuracy, and consistency. Focus on ongoing process enhancement for safety operations such as developing standard procedures and templates, and the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the PV activities.

Location: Based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Draft or review documents produced for regulatory agency safety inquiries for scientific content and alignment with company position, clarity, accuracy, and consistency; facilitate document review by other contributors.
• Participate in ongoing safety data review and analysis for assigned products and ICSR case management, as well as maintenance of safety database and creation of processes involving handling case reports within the safety database.
• Interface with other hirify.global functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
• Contribute to on-going process enhancement for safety operations such as developing standard procedures and templates, and the development, production, and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the PV activities.
• Participate in internal global PV meetings as well as joint safety meetings with partners if needed.
• Collaborate with designated Contract Research Organizations (CROs) and Vendors, as assigned by the PV Head.

Requirements

• Minimum five (5) years in Drug safety/PV in pharmaceutical industries setting with both investigational and marketed products.
• Knowledge of Drug safety database (Argus) and E2B R3.
• Knowledge of case report management processes including case receipt, case processing, medical review, and regulatory submission.
• At least two (2) years of experience with local aggregate safety reports.
• Bachelor's, Master’s or Doctorate level degree in pharmacy, nursing, or other healthcare-related profession or life sciences required.
• Must have excellent verbal and written communication skills (verbal and written / Japanese and English).

Culture & Benefits

• Flexible working hours and comprehensive leave system.
• Retirement benefit plan, stock reward plan, and employee stock ownership plan (ESPP) participation opportunities.
• In-house training, external training program utilization, LinkedIn Learning, and specialized professional training.
• AI-powered learning tools and digital assistants to support access to in-house resources.
• Global recognition programs and employee resource group activities.
• Hybrid work environment with the latest technology for seamless collaboration across locations and time zones, and a comprehensive IT support system.