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Job Description

Associate Manager, Safety Operations(1 year contract)

首尔特别市, 韩国 R1509387 Hybrid

首尔特别市, 韩国

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职位描述

Job Overview

This position is responsible for ensuring that all local operating company (LOC) safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels, as well as in accordance with any product vigilance agreements with third-party business partners.

This role will serve as the main point of contact for pharmacovigilance (PV) matters with the local health authority for the assigned LOC and territories. This role ensures that appropriate product vigilance and risk management systems are in place to provide oversight of products within their responsibility.

Essential Functions

• Act as the Local Nominated Person for pharmacovigilance in respective countries, assuming the PV role as defined by national law and collaborating with QPPV offices as required.
• Provide oversight of the local PV system, including vendor management, coaching of direct reports.
• Maintain up-to-date knowledge of local pharmacovigilance and ensure implementation in collaboration with global teams.
• Oversee adverse event reporting, respond to safety-related health authority queries, ensure training and awareness of safety reporting among LOC personnel, and manage local literature surveillance.
• Collaborate with global and local teams to notify health authorities of safety issues, ensure PV compliance in local company-sponsored programs, and contribute to risk management and safety reporting.
• Provide technical and strategic input to local or global PV projects and initiatives.
• Maintain and update local procedures as needed, ensuring alignment with global procedural changes.
• Support audit and inspection readiness, including local health authority inspections and audits, and implement CAPA plans as applicable.
• Manage PV contract clauses in local agreements and ensure proper business continuity planning related to PV operations.

Qualifications
• 1-year contract position
• Bachelor's degree in life sciences or related field more than 5 years of pharmacovigilance experience or relevant experience.

• A pharmacist is preferred

• Fluent in both spoken and written English

• Strong decision-making capabilities

• Ability to attend the office 2-3 times per week

• Proficient people management skills

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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