[담당업무]

The Position
As a PV Associate Manager, you are responsible for supporting the maintenance of the compliance and quality of the affiliate pharmacovigilance system. You will timely update the PV oversight system with local requirements for Pharmacovigilance System Master File (PSMF) by conducting gap analysis and updating relevant PV Standard Operating Procedures (SOPs)　and quality checks of customer contacts according to Novo Nordisk (NN) procedures.

Main accountabilities are as follows, but are not limited to:
• Ensure reporting of safety information from spontaneous and solicited sources of marketed products and clinical trials to Global Safety (GS) and Health Authority (HA) in accordance with local regulation and NN procedures. Conduct the quality check on the cases reported by PV associate and PV assistant. Oversee and supervise safety information reporting conducted by the business partners and service vendors.
• Handle safety information reported by Novo Nordisk personnel and distribute Individual Case Safety Report (ICSRs) and aggregate safety reports to Korea Clinical Development Center and report to HA, if needed.
• Prepare PV audits and HA inspections. Manage internal projects with Global Safety or region PV.
• Prepare and lead the management of the Risk Management Plan (RMP) with relevant stakeholders as required by relevant regulations. Provide training regarding pharmacovigilance to internal & external stakeholders and manage Safety Data Exchange Agreement (SDEA).
• In the absence of local Qualified Person for Pharmacovigilance (QPPV), back-up the activities as per the duration.

Qualifications
• You hold a bachelor’s degree in Pharmacy, Life Science, Nursing or a related scientific field.
• Pharmacist is preferred.
• At least 5 years of relevant experience in Pharmacovigilance is preferred.
• Proficiency in both speaking and writing in English and local language is essential.

[자격요건]

경력사항: 경력(5년 이상 )
학력사항: 대학교(4년)졸업 이상

*The actual position title can be changed according to the applicant’s relevant experience in Pharmacovigilance.