Senior Specialist Drug Safety

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.

Why its Great to work at DKSH

At DKSH we are driven by a purpose that goes beyond the ordinary: enriching peoples lives. Through the products and services we provide DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference!

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