Job Description:
The Role
The Pharmacovigilance Senior Specialist (PV Senior Specialist) will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization reporting to the head of Japan Pharmacovigilance.
The PV Senior Specialist is responsible for all PV activities and may communicate with local stakeholders, headquarters (HQ), and the local health authority. Collaboration with colleagues is essential to ensure compliance with local laws and regulations, avoid gaps in adverse event reporting, and maintain safety oversight.
The Sr. Specialist's duties include management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections, SOP management, local training, communicating safety issues, people development, and special projects. They may also act as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV.
In addition, the Sr. Specialist oversees daily PV processes, ensures alignment with PV systems, executes local PV activities following SOPs, and maintains regulatory data in accordance with company policies. They support audits, develop local procedures, lead training initiatives, and liaise with business partners on PV-related matters.
- Serve as the back-up PV Responsible person/Safety Management Supervisor as needed by local PV legislation
- Oversee daily PV processes within covered countries
- Execute local PV processes in alignment with PV systems and Quality Management System
- Perform reconciliation activities for PV cases from local units and partners
- Support Patient Support Programs and Market Research activities, file safety-related data
- Ensure compliance with global and local SOPs, report any deviations immediately
- Support local PV audits, inspections, and development of CAPAs
- Participate in audits of vendors, conduct due diligence activities
- Identify procedural gaps and implement solutions
- Lead training initiatives and ensure compliance with local agreements
- Support the oversight of Risk Minimization Measures and ARMMs
- Act as the local Health Authority point of contact for PV-related inquiries
Requirements:
- Over 15 years of experience in pharmacovigilance
- Degree in life sciences
- Native level Japanese, Business Level English
- Experience managing teams
- Positive attitude, negotiation skills, and leadership qualities
Preferred Skills:
- Knowledge of medical devices
- Experience with investigational drugs safety information
Secondary Job Description
About Us:
As a company dedicated to improving women's health, Organon focuses on delivering innovative health solutions to enhance the lives of women, their families, and communities. We prioritize addressing the unmet needs of Women's Health, expanding access to biosimilars, and providing diverse health solutions.
Our commitment to diversity is reflected in our equal opportunity employment policy. We strive to create an inclusive environment for all applicants.
Annualized Salary Range
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements
Shift:
Valid Driving License:
Hazardous Materials:
Number of Openings:
1Requisition ID: R525722
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