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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.