Pharmacovigilance Specialist (Drug Safety)

TL;DR

Pharmacovigilance Specialist (Drug Safety): Managing drug safety and pharmacovigilance operations for investigational and marketed products with an accent on regulatory compliance, safety database maintenance, and quality assessment. Focus on leading aggregate safety reporting, supporting regulatory inquiries, and ensuring inspection readiness in collaboration with global teams.

Location: Must be based in Tokyo, Japan (Hybrid work model).

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, recognized as a top employer in science and innovation.

What you will do

• Manage ICSR case processing and maintain safety databases including Argus.
• Lead local aggregate safety reporting processes such as J-DSUR and J-RMP.
• Develop and maintain tracking and compliance tools for PV activities.
• Coordinate PV inspection readiness and quality assurance activities.
• Draft responses to regulatory inquiries from agencies, EC, and IRB.
• Participate in internal global PV meetings and joint safety meetings with partners.

Requirements

• Minimum 5 years of experience in Drug Safety/PV within the pharmaceutical industry.
• At least 2 years of experience with local aggregate safety reporting and J-RMP.
• Bachelor’s, Master’s, or Doctorate degree in pharmacy, nursing, or life sciences.
• Working knowledge of FDA, EU, and ICH guidelines, GCP, and MedDRA.
• Proficiency with safety databases (Argus) and E2B R3 standards.
• Must be based in Tokyo, Japan.

Nice to have

• Master’s in Public Health (MPH) or MBA.

Culture & Benefits

• Flexible working hours and hybrid work environment.
• Comprehensive vacation and leave policies.
• Retirement benefits, stock options, and employee stock purchase plan (ESPP).
• Extensive career development support including LinkedIn Learning and professional training.
• Modern office space in central Tokyo with collaborative cafe areas.