Manager, Drug Safety

Job Title: Manager, Drug Safety

Location

Hong Kong

Overview

We are seeking an experienced Manager, Drug Safety to oversee pharmacovigilance activities and support the safe, compliant use of healthcare products in Hong Kong. This role is responsible for maintaining effective drug safety processes, managing adverse event reporting, and ensuring activities meet applicable regulatory requirements and internal standards.

The ideal candidate will bring strong pharmacovigilance expertise, sound knowledge of local and international safety regulations, and the ability to work effectively with regulatory, medical, quality, and commercial teams.

Key Responsibilities

• Pharmacovigilance Operations

  • Oversee the collection, assessment, documentation, and reporting of adverse events and other safety information.
  • Ensure safety cases are processed accurately and submitted within applicable timelines.
  • Maintain and improve local drug safety procedures and work instructions.

• Regulatory Compliance

  • Monitor relevant pharmacovigilance requirements in Hong Kong and support compliance with applicable local and international regulations.
  • Coordinate safety-related submissions, notifications, and responses to regulatory authorities, as required.
  • Maintain accurate records and ensure documentation is inspection-ready.

• Safety Monitoring & Risk Management

  • Support ongoing safety surveillance, signal detection, and evaluation of emerging safety concerns.
  • Contribute to the preparation and review of periodic safety reports, risk management documentation, and other safety deliverables, as applicable.
  • Escalate potential safety issues to relevant stakeholders promptly.

• Safety Agreements & Partner Oversight

  • Review and maintain pharmacovigilance agreements with business partners and service providers.
  • Monitor third-party performance and ensure responsibilities, reporting timelines, and escalation processes are clear.

• Audit & Inspection Readiness

  • Coordinate pharmacovigilance audits and inspections, including preparation, document management, and follow-up actions.
  • Track and support the resolution of audit findings and corrective and preventive actions.

• Training & Stakeholder Engagement

  • Develop and deliver drug safety training to relevant employees and partners.
  • Advise cross-functional teams on adverse event reporting requirements and pharmacovigilance processes.

• Team & Process Management

  • Lead, coach, and develop drug safety team members.
  • Identify opportunities to strengthen processes, improve quality, and support efficient case handling.

Qualifications

• Experience

  • Typically 5–8+ years of experience in pharmacovigilance or drug safety, preferably with experience managing local or regional activities.

• Education

  • Degree in pharmacy, medicine, life sciences, or a related discipline.

• Regulatory Knowledge

  • Strong understanding of pharmacovigilance principles and relevant safety reporting requirements.
  • Familiarity with Hong Kong requirements and international guidelines is highly desirable.

• Technical Expertise

  • Experience with adverse event case processing, safety reporting, signal management, and pharmacovigilance documentation.
  • Familiarity with safety databases and quality management systems is an advantage.

• Leadership & Collaboration

  • Demonstrated ability to lead projects or teams and work effectively with cross-functional stakeholders.
  • Strong organizational skills and the ability to manage multiple priorities and deadlines.

• Communication

  • Excellent written and verbal communication skills in English. Cantonese and/or Mandarin proficiency is an advantage.

Why Join This Organization?

This is an opportunity to take ownership of important drug safety activities and help strengthen patient safety and regulatory compliance. If you are a detail-oriented pharmacovigilance professional who combines sound technical knowledge with strong leadership and stakeholder skills, we encourage you to apply.