Manager, Drug Safety

DKSH

Hong Kong

On-site

HKD 900,000 - 1,300,000

Full time

17 hours ago
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Job summary

DKSH is expanding its Regulatory Services in Hong Kong and seeks a Manager, Drug Safety to lead Pharmacovigilance (PV) and Medical Device Vigilance (MV) programs. You will ensure rigorous regulatory compliance, engage with clients and HCPs, and build a capable, high-performance Drug Safety team.

Key responsibilities include ensuring SDEAs/MDVAs alignment, timely safety reporting, audits readiness, and proactive training for staff and healthcare professionals.

Qualifications

  • Bachelor's degree in science, chemistry, pharmaceutical sciences or related discipline.
  • Minimum 5 years of experience in the medical or pharmaceutical industry.
  • Sound knowledge of pharmaceutical products and local regulatory requirements in Hong Kong.
  • Strong communication and interpersonal skills for engaging with clients, HCPs and cross-functional teams.

Responsibilities

  • Drive end-to-end Pharmacovigilance (PV) and Medical Device Vigilance (MV) programs in Hong Kong.
  • Ensure PV/MV obligations are met per SDEAs, MDVAs and local guidance.
  • Oversee timely reporting of adverse events to clients and Health Authority.
  • Lead PV/MV audits readiness and CAPA development.
  • Develop and deliver PV/Vigilance training to staff and HCPs.
  • Present accurate reports and lead client meetings to maintain partnerships.
  • Inspire the Drug Safety team to achieve goals and foster continuous development.

Skills

PV & MV Knowledge
Regulatory Liaison
Leadership
Communication

Education

Bachelor's Degree (Science/Pharma)

Job description

About DKSH

DKSH’s purpose is to enrich people’s lives. For over 160 years, we have been marketing, selling, and distributing high-quality products and brands for multinational and Fortune 500 companies. Through our Business Units Consumer Goods, Healthcare, Performance Materials, and Technology, we deliver sustainable growth for our partners. We contribute to improving the quality of life for our employees and people in the local communities in which we operate. Headquartered in Switzerland, DKSH is publicly listed and operates in 35 markets across Asia Pacific, Europe, and North America. We employ over 26,800 specialists and produced net sales of CHF 11.1 billion in 2025.

About The Role

The Manager, Drug Safety leads the end-to-end implementation of Pharmacovigilance (PV) and Medical Device Vigilance (MV) programs across Hong Kong, ensuring rigorous regulatory compliance and the highest standards of patient safety. This role is integral to DKSH’s Regulatory Services function, driving client confidence through vigilance excellence and building a capable, future-ready team.

General Responsibilities
  • Drive the implementation of Pharmacovigilance (PV) and Medical Device Vigilance (MV) policies, strategies, and objectives across the Hong Kong market in alignment with company standards
  • Ensure company staff consistently meet PV/MV obligations as defined in Safety Data Exchange Agreements (SDEAs), Medical Device Vigilance Agreements (MDVAs), quality documents, and local Health Authority guidance
  • Oversee the rapid and timely reporting of adverse events to clients and/or the Health Authority, upholding the highest standards of regulatory integrity
  • Conduct regular literature reviews to support ongoing drug safety surveillance and evidence-based risk assessment
  • Ensure medicinal products subject to drug safety programs reach only registered and trained healthcare professionals (HCPs) or approved target audiences in strict accordance with program specifications
  • Design and deliver targeted drug safety training to internal staff and HCPs, strengthening compliance capability and program effectiveness
  • Develop and present accurate, timely reports and lead regular client meetings to maintain transparency and reinforce strategic partnerships
  • Lead organizational readiness for internal and client PV/MV audits, including the development and execution of Corrective and Preventive Action (CAPA) plans
  • Manage and inspire the Drug Safety team to consistently deliver against function goals, fostering accountability and a high-performance culture aligned with DKSH values
  • Champion the learning and development of team members in Drug Safety, building the next generation of regulatory professionals
  • Administrative duties and coordination tasks as required
Requirements
  • Bachelor's Degree in Science, Chemistry, Pharmaceutical Sciences, or a related discipline
  • Minimum 5 years of experience in the medical or pharmaceutical industry
  • Sound knowledge of pharmaceutical products and local pharmaceutical regulatory requirements in Hong Kong
  • Strong communication and interpersonal skills, with the ability to engage effectively with clients, healthcare professionals, and cross-functional teams
See What You Can Do!

At DKSH, we offer you breadth that accelerates growth, trust that lets you lead, and purpose that connects your work to the things people depend on every day. As DKSH spans industries, markets, and segments, serving thousands of customers, you'll build expertise that is rare, well rounded, and difficult to replicate elsewhere. You'll be trusted to own your role and supported to deliver real results. The impact of your work extends far beyond your role. Through the work you do, you are an essential part of making, powering, and improving everyday life.

Learn more about working at DKSH: https://www.dksh.com/careers

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