Job Overview

The senior safety specialist will contribute to maintain Pharmacovigilance systems, operations and procedures in place within the Affiliate, as delegated.

Responsible for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate as delegatedContributor across the broader International Pharmacovigilance and Global Pharmacovigilance, as required

Essential Functions

Implement and maintain a pharmacovigilance system authorized in the territory and ensure compliance with applicable regulatory and company requirements;Work in close collaboration with corporate Pharmacovigilance teams to contribute in the maintenance of the PV system according to regulatory requirements and the company standards. Support the maintenance of quality management system related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs; maintain oversight of local deliverables delegated to service providers.Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to Global/EEA QPPV (as applicable) office, either directly or through local delegations.Collaborate with program owners and other cross functional stakeholders to co-create optimal program solutions for patients that are in compliance with the regulations;Proactive assessment of the capability and capacity of PSP/MRP vendors to conduct critical pharmacovigilance tasks (in support of qualification audits) and avoid issues of regulatory compliance.Provide safety input for Post marketing surveillance studies or drive Post marketing survey and ensure the safety reporting as per the company process.

Required Qualifications

Strong pharmacovigilance experience supporting a client’s Korea affiliate, with a focus on day-to-day PV operational activities, including vendor oversight and governance (excluding direct case processing)Proven experience supporting Korean Post-Marketing Surveillance (PMS) activities, ideally including PV support for KR PMSSolid experience in Korea RMP-related activities, including maintenance and revision of KR RMPs, Preparation of RMP implementation and evaluation reports.In-depth knowledge of Korean local regulatory requirements related to pharmacovigilance, with a minimum of 3 years of relevant professional experienceAbility to work independently within a Korean regulatory environment while collaborating closely with local Korean teams and global stakeholdersFluency in both Korean and English, with strong written and verbal communication skills

Preferred Qualifications

Registered pharmacist qualificationPrior experience working with global stakeholders in a matrix or multinational environment

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