Job Description

About the Role

We are seeking a highly motivated Senior Specialist, Drug Safety to support and ensure compliance with Pharmacovigilance (PV) and Medical Device Vigilance (MV) requirements across our Healthcare business. This role plays a key part in safeguarding patient safety, maintaining regulatory compliance, and supporting clients through effective safety surveillance and reporting activities.

General Responsibilities:

• Implement and maintain Pharmacovigilance (PV) and Medical Device Vigilance (MV) policies, strategies, and objectives in compliance with company and client requirements.
• Ensure compliance with PV/MV obligations as outlined in Safety Data Exchange Agreements (SDEAs), Medical Device Vigilance Agreements (MDVAs), quality documents, and local regulatory requirements.
• Ensure the timely processing and reporting of adverse events to clients and/or health authorities.
• Conduct literature surveillance and identify potential safety signals or emerging safety concerns.
• Support the implementation and monitoring of risk management plans, educational programs, and risk minimization measures.
• Collaborate with clients and Regulatory Affairs on periodic safety reporting and responses to safety-related enquiries.
• Monitor PV/MV compliance metrics, perform reconciliation activities, and ensure adherence to safety agreements and contractual obligations.
• Develop and deliver PV/MV training programs and maintain accurate, inspection-ready training records.
• Support internal audits, client audits, regulatory inspections, and the implementation of corrective and preventive actions (CAPAs).
• Act as the local PV/MV contact for clients and stakeholders, providing compliance reports, safety updates, and ongoing operational support.

Job Requirements:

• Degree or above in Science, Chemistry, Pharmaceutical or related disciplines

• Minimum 4 years of experience in medical or pharmaceutical industry
• Sound knowledge in pharmaceutical products and local pharmaceuticals regulatory requirements
• Good communication and interpersonal skills
• Fluency in English and Chinese, both written and spoken
• Proficiency in Microsoft office (Excel, Word and PowerPoint)
• Candidates with more extensive experience may be considered for the Manager position.