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• Bachelor’s degree in in life, health or pharmaceutical sciences is preferred
• Have 2-3 years Quality inspection / Pharmacovigilance or relevant working experience.
• Good verbal and written communication skills in English and local language.
• Knowledge and understanding of key legislation applicable to pharmacovigilance within,
• Strong medical background (A degree in life, health or pharmaceutical sciences is preferred e.g. Pharmacist, Medical doctor, Biologist).
• Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable
• Strong computer skills including Microsoft Office and databases. Adapt to all kinds of English operation/system interface.
• Data collection, management and analysis skills.
Role Summary & Responsibility :
• Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
• The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the ASPAC Region (centralized case management) are carried out in a timely manner.
• Inbound & outbound ICSR case management.
• Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.
• Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional
• Represent IPV Case management or support the LSO, in matters pertaining to audit or inspection preparation or conduct.
• Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
• Vendor AE intake oversight.
PERSOLKELLY is one of the largest recruitment companies in Asia Pacific providing comprehensive end-to-end workforce solutions to clients.
Headquartered in Singapore, the company was established in 2016 and is a joint venture between Kelly Services, Inc. and affiliates of PERSOL HOLDINGS Co. Ltd.
PERSOLKELLY is a regional specialist with a depth and breadth of expertise and capability, as we have experience in the realities of your world and can open you to opportunities across ours. All businesses seek the winning combination of talent, knowledge, and experience. Coming together as one strong regional business means you benefit from our expansive reach and strong experience; our connections and depth of expertise becomes yours.
Today, PERSOLKELLY operates more than 45 offices across 13 markets including Australia, China, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, and Vietnam.
For more information, please visit www.persolkelly.com