Drug Safety Operations Manager - Japanese speaking to communicate with Japanese stakeholders

AFFINITY HUMAN VENTURE LLP; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading company is seeking a Safety Operations Manager for the APAC region, responsible for overseeing safety processes, coordinating deliverables, and ensuring compliance with regulations. This remote role requires extensive experience in drug safety, fluency in both English and Japanese, and the ability to travel extensively.

Qualifications

• Several years of experience in Drug Safety and Pharmacovigilance.
• Work experience in a CRO environment.
• Experience with a Japan market.

Responsibilities

• Oversees safety vendor and GPS teams regarding case triage and processing.
• Coordinates with internal and external parties on safety deliverables.
• Identifies issues and leads improvements in processes.

Skills

Drug Safety

Pharmacovigilance

Fluency in English

Fluency in Japanese

Job description

Safety Operations Manager – APAC

Clinical research

Location: remote: Australia/Singapore/Taiwan/Philippines or India

Job Description
Oversees and coordinates with safety vendor and GPS teams regarding case triage and
processing, expedited and aggregate reporting
Coordinates with and supports deliverables with GPS GSL team in relations to case
processing
Collaborates with other internal teams (including clinical, medical, or regulatory) and external
parties (including HCPs, consumers, or contracted resources) regarding safety related
deliverables and processes
Communicates within argenx and with business partners or distributors regarding
deliverables related to PV Agreements (PVA) / Safety Data Exchange Agreements (SDEA).
Oversees assignment of Safety Specialist tasks, i.e. regarding timely monitoring of GPS
communication
Proactively identifies issues and areas for improvement and escalates appropriately
Proactively engages in the development of new processes and procedures and leads
implementation of those
Performs all activities in compliance with applicable argenx Controlled Procedures and with
global and local regulations as applicable.
Performs other tasks as assigned by line manager or Head of GPS
Requirements:
Several years of experience in Drug Safety and Pharmacovigilance
Work experience in a CRO environment
Experience with a Japan market
Fluency in English and Japanese
Ability to travel extensively

Application Process
Email: [e-mail]
Schedule a confidential call: https://calendly.com/sarka_llorens/15min
EA License No: 17S8637 | Reg No: R1329451