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About the Role

Our client is seeking a Drug Safety Specialist to support pharmacovigilance activities and safety-related projects. The role involves accurate and compliant processing of safety information, ensuring adverse events are assessed, documented, reported, and followed up according to regulations and GVP. This is an opportunity for a pharmacovigilance professional to gain experience in a regulated, international environment.

Responsibilities

Support Patient Safety & Risk Management projects and ensure project deliverables are completed in accordance with quality and compliance requirements.
Process safety information and potential adverse events in line with GVP, SOPs, and client-specific procedures.
Evaluate adverse events and follow-up reports, including assessment of seriousness and other relevant safety criteria.
Ensure appropriate reporting and follow-up of adverse events and product complaints associated with adverse events.
Maintain accurate and complete safety information within pharmacovigilance databases.
Process and report safety data in accordance with applicable regulatory and client requirements.
Conduct literature surveillance and searches of regulatory authority sources for adverse event information.
Participate in internal and external audits and support associated activities.
Assist with the preparation and maintenance of SOPs and other pharmacovigilance documentation.
Support Project Managers and Patient Safety Managers/Senior Managers with activities such as SOP development and Safety Data Exchange Agreements.
Maintain high standards of data integrity, documentation, and regulatory compliance across all assigned activities.

Requirements

Bachelor's degree or equivalent in Health Sciences or a related discipline.
At least 1 year of experience in drug safety, pharmacovigilance, or an equivalent role within a highly regulated industry such as pharmaceuticals or medical devices.
Good working knowledge of Japanese regulatory requirements for adverse event management and reporting.
Understanding of applicable pharmacovigilance requirements in Australia, New Zealand, and the EU.
Experience working with safety databases.
Practical experience with SOP writing and document management.
Strong attention to detail and a high level of computer literacy.
Excellent communication, organizational, and problem-solving skills.
Strong ability to manage multiple priorities while maintaining accuracy and compliance.

Skills

Pharmacovigilance
Safety databases
Literature surveillance
Audits
SOPs
Regulatory compliance
Case processing
Document management
Communication
Organization
Problem-solving
Attention to detail
Computer literacy

Location

Hybrid

Work Type

Hybrid

Experience Level

At least 1 year

Education Level

Bachelor's degree or equivalent in Health Sciences or a related discipline

Benefits

Join an experienced Patient Safety & Risk Management team working across international pharmacovigilance projects.
Gain exposure to Japanese, Australian, New Zealand, and EU pharmacovigilance requirements.
Develop hands-on expertise across case processing, safety databases, literature surveillance, audits, SOPs, and regulatory compliance.
Work on projects with a direct connection to patient safety and healthcare outcomes.
Flexible hybrid working environment.
Opportunity to develop within a growing international pharmacovigilance organization.