[한국GSK] RA Specialist · PV Associate 모집 (~ 3/1 마감)

[HR팀]

[글락소스미스클라인(GSK)]

GSK Pharma - RA Specialist / GSK Consumer - PV Associate 채용

GSK는 사람들이 ‘건강하고 활기차게 삶을 살 수 있도록(do more, feel better, live longer) 돕는 것’을 사명으로 하는 연구개발 중심의 글로벌 헬스케어 기업으로 제약, 백신, 컨슈머 헬스케어 세 사업을 중심으로 혁신적인 제품을 연구 개발하고 있습니다.

GSK는 세계 150개국 이상에 진출해 있으며 약 9만 5천여 명의 직원들이 일하고 있습니다. 본사는 영국 Brentford에 있으며, 영국, 미국, 벨기에, 이탈리아, 중국 등지에 첨단 R&D시설을 갖추고 전세계 약 11,000명의 R&D 인력이 새로운 치료제, 백신, 컨슈머 헬스케어 제품의 연구개발에 매진하고 있습니다.

GSK는 혁신적인 치료제, 백신, 컨슈머 헬스케어 제품을 연구 및 개발, 생산하고 있으며, 1986년 국내에 진출한 이래 우수한 의약품과 건강관리 제품으로 환자 및 소비자의 접근성을 향상시키는 지속적인 노력과, 다양한 임상연구 유치 및 책임 있는 기업 활동을 통해 환자 및 소비자를 위한 특별한 가치를 창출하고, 이 가치는 GSK를 일하기 좋은 회사로 만드는 데 중요한 지침이 됩니다.

특히 GSK Korea는 제약 및 백신 사업을 총괄하는 GSK 한국법인과 헬스케어 사업을 이끄는 GSK 컨슈머 헬스케어를 설립하여 두 법인 체제로 운영되고 있습니다.

• 제약 : 천식, COPD 등의 호흡기 질환을 비롯해 항암제, HIV, 면역, 감염 등 다양한 질환에 대한 치료제 제공

• 백신 : 소아, 성인의 질환예방을 위한 폭넓은 백신 포트폴리오 제공 (글로벌 30종 이상, 국내에 15종 이상의 백신 출시)

• 컨슈머 헬스케어: 구강 관리, 피부 건강, 웰니스 등의 영역에서 다양한 소비자 건강관리 제품 및 일반 의약품 제공

[모집부문] GSK Pharma - RA Specialist (1Y contract)

• 계약 조건 : Full-Time(1Y contract)

• 모집분야 : Regulatory Affairs

• 나이/성별 : 무관

• 학력 : 대졸(4년)

• 경력 : 신입 또는 1년 이상

• 지원방법 : 채용홈페이지 지원

• 서류마감 : 3월 1일 마감

Key Responsibilities:

The Regulatory Specialist will play a key role in submissions to ensure the successful delivery of an overall regulatory plan. The specialist will lead interactions with the LOC’s and central teams, ensuring regulatory plans are able to meet the business goals. The role will be exposed to a variety of regulatory activities and, in time, will be given opportunity to take on more strategic regulatory responsibilities as the role grows alongside the personal capability and potential.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

w Responsibility for leadership of, preparation and review of day to day regulatory submissions with full accountability for delivery

w Accountability for larger submissions as part of an overall project plan i.e. initial submissions and responses to questions

w Working with Global Regulatory Lead/Regional Representative/Team Manager, to develop regulatory strategy

w Ensuring quality of both own and teamwork and compliance with regulatory guidelines and process within the required timelines

w Liaising with Regulatory Agencies to resolve straight forward issues in relation to their accountabilities

w Implementation of the submission strategy

w Responsible for the maintenance activities associated with with the Approved products / Investigational products

Why You?:

w Bachelor’s Degree in Pharmacy / Biological / Chemical Science etc.

w 1+ year of relevant experience in Regulatory Affairs or IND including the leadership and delivery of a range of regulatory submissions

w Knowledge of regulatory agency guidelines and expectations in the submission process

w Experience of the regulatory agency review process

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[모집부문] GSK Consumer - PV Associate (1Y contract)

• 계약 조건 : Full-Time(1Y contract)

• 모집분야 : Pharmacovigilance Associate

• 나이/성별 : 무관

• 학력 : 대졸(4년)

• 경력 : 2년 이상

• 지원방법 : 채용홈페이지 지원

• 서류마감 : 3월 1일 마감

Role Purpose:

Liaison and strategic partner to GSK Consumer Healthcare (CH) to ensure oversight and management of Pharmacovigilance activities to comply with internal standards and local regulations.

Key Responsibilities:

Support General Managers & CH Head of Safety with:

w Annual review and negotiation of PV SSA as it pertains to the local operating company (LOC)

w Understanding how changes in PV processes and/or legislation impact the LOC

w Escalation of PV issue or risk that may impact patient safety or the CH business

Back up for Local QPPV who is required by local regulation responsible for:

w Ensuring the compliance for regulatory requirements and internal standard for local CH PV related activities

w Acting as LOC point of contact relevant to PV management for local regulatory authority, internal/external stakeholders, and global PV service provider to comply with local regulatory requirements and manage escalated cases when required

Manage routine CH PV activities such as:

w Creating, revising and maintaining PV LSOPs and work instructions, and reflecting the changes of regulatory requirements and/or internal standards into them

w Close and periodic communication with and local guide provision to contracted PV service provider for:

▶ Collection of Human Safety Information/Adverse Events (HSI/AEs) and reporting of HSI/AEs to Central Safety Depts

▶ Timely reporting of AEs/SAEs to the local regulatory authority as required

▶ Local Safety Data Exchange Agreement relevant activities such as revision and liaison with Partner’s PV contact to check the compliance

w Submission of PSURs and other periodic safety updates to Regulatory Authorities, Investigators and Ethics Committees as required

w Ensuring LOC PV’s quality, workload and document management

w Keeping up to date with changes to internal and/or external requirement to ensure appropriate implementation of PV activities at local level

w Promptly informing of any deviations, issues or risks identified for the PV activities and implementing corrective actions or risk mitigation activities as appropriate

w Leading audits & inspections on CH business

w Performing delegated PV activities (e.g. Human Safety Information training, review of third-party contracts)

Basic Qualifications:

w Experience with Good Clinical Practices (GCCP), clinical safety documentation and reporting of adverse

w BSc level degree in pharmacy or medicine (Regulatory requirement for local QPPV: physician, pharmacist or oriental pharmacist licensed in Korea)

w 2+ years of experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH with safety or pharmacovigilance experience

Preferred Qualifications:

w Physician, pharmacist or oriental pharmacist licensed in Korea (qualification of QPPV)

w Strong judgment and analytical skills

w Ability to work independently and drive performance standards

w Effective negotiating, influencing and persuasion skills

w Strong verbal and written communication skills in English/other local required languages