Senior Specialist Drug Safety
DKSH · Wong Chuk Hang
Job description
About the role
We are looking for a highly motivated Senior Specialist in Drug Safety to ensure compliance with Pharmacovigilance (PV) and Medical Device Vigilance (MV) requirements across our healthcare business. The role safeguards patient safety, supports regulatory compliance, and provides effective safety surveillance for our clients.
Key responsibilities
- Implement and maintain PV and MV policies, strategies, and objectives in line with company and client requirements.
- Ensure compliance with safety data exchange agreements, medical device vigilance agreements, quality documents, and local regulations.
- Process and report adverse events to clients and health authorities in a timely manner.
- Conduct literature surveillance to identify safety signals or emerging concerns.
- Support risk management plans, educational programs, and risk‑minimisation measures.
- Collaborate with clients and Regulatory Affairs on periodic safety reporting and enquiry responses.
- Monitor compliance metrics, perform reconciliations, and uphold contractual safety obligations.
- Develop and deliver PV/MV training, maintain inspection‑ready records, and support audits and inspections.
Required profile
- Degree or higher in Science, Chemistry, Pharmacy or a related discipline.
- Minimum 4 years of experience in the medical or pharmaceutical industry.
- Strong knowledge of pharmaceutical products and local regulatory requirements.
- Excellent communication and interpersonal abilities.
- Fluency in written and spoken English and Chinese.
Required skills
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
What we offer
- Opportunity to work in a purpose‑driven company that enriches people’s lives.
- Flexible work arrangements that combine entrepreneurship with stability.
- A supportive environment for professional growth and making a meaningful impact.
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Published 1 month ago
Expires 4 weeks from now
33 views · 0 interested
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DKSH
Wong Chuk Hang