As Pharmacovigilance Specialist, has overall responsibility for the day-to-day management of pharmacovigilance for marketed products and products in clinical trials, including all Pharma products, and Vaccines for activities that Korea LOC is accountable for.
This includes ensuring compliance with all local regulations and GSK global pharmacovigilance requirements and includes but is not limited to the following activities.
Develop, update and maintain local PV written standards by monitoring internal & external regulations and standards and ensure updated and accurate information is reflected.
Ensure timely reporting of Individual Case Safety Reports Submissions to the local regulatory authority as required, through diligent oversight.
Develop local Risk Management Plans (RMPs) and oversee the implementation of RMPs locally, including additional Risk Minimization Measures (aRMMs), when required.
Submit periodic reports of local RMPs implementation, PBRERs and other periodic safety updates (aggregate report) to Regulatory Authorities as required and prepare safety reports for Product Renewals.
Ensure training of all local operating company staff in Human Safety Information reporting as required.
Ensure that Pharmacovigilance Agreements (PVAs) and Safety Clauses (PVASC) are appropriately established and managed as the PVASC author, when required.
Provide safety reports (SUSAR, SUSAR line listings) to relevant local team for dissemination to investigators, or directly to investigators when required.
Perform management monitoring in line with the requirements.
Be responsible for quality management, issue management and document management across all local PV activities if required.
Requirements
Bachelor’s degree, Medical science background
Pharmacist (preferred)
More than 2 years of experience in Pharmacovigilance or Clinical Trials.
Communication and presentation skills
Proficient in Korean and English
Knowledge of local regulations affecting pharmacovigilance
*LI-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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