가천대학교

[근무회사 및 모집부문]

*근무회사:한국아이큐비아㈜

*홈페이지:https://www.iqvia.com/

*사업분야:건강정보기술 서비스 및 임상수탁전문기업

* Job Family: Safety Operations

* Job Title: Medical Information (프로젝트 성 채용)

*근무형태: Home Based (재택근무)

*외국계 기업 /제약회사 경력에 관심이 있는 후보자에게 좋은 채용 건입니다.

*글로벌 기업으로 높은 Name Value및 기업문화 등 다양한 이점을 보유한 기업입니다.

*프로젝트로 인한 다수의 후보자를 채용하기에 많은 관심 부탁 드립니다.

[회사소개]

본 기업은 건강정보기술 서비스와 의약품 개발 및 아웃소싱 서비스를 제공하며,주로 임상 1상에서 4상까지의 시험 및 컨설팅 서비스를 포함한 실험실 분석 서비스 제공에 중점을 두고 있습니다.

[전반적인 직무소개]

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

[업무내용]

- Receive, triage, review and process Lifecycle safety operational data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission.

- Assess Lifecycle safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.

- Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.

- Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting operational data.

- Process Lifecycle safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.

- Build a positive, collaborative team environment with Lifecycle safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations with appropriate allocation of resource.

- Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.

- Provide and impart technical and process information to Lifecycle Safety Management (LSM) and members of operational team on project specific issues.

- Provide oversight and maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.

- Establish and maintain effective team project service operations communications i.e. provide regular feedback to operations team manager and Customer Delivery manager (CDM) on project metrics, out of scope work challenges/issues and successes; feedback effective project performance to junior members of team.

- Liaise with LSM contact in proactively identifying issues and proposing solutions, providing them with technical support, reports, metrics, statuses, identifying SOW changes and potential change orders, delegating client requests and installation of new initiatives.

- Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.

- Participate in training across Lifecycle safety process service offerings, participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.

- Liaise confidently with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.

- Contribute to achieving productivity utilization and realization metrics.

- Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required.

- Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.

- Perform other duties as assigned.

[지원자격]

- 4년제 대학 졸업 이상 (신입 지원 가능)

-유관 업무 경력(인턴포함)및 Pharma & Medical Company 경험자 우대

-관련 전공자 우대 (약학,생명공학, 바이오, 간호학,제약산업공학 등 이공계 전공자)

-임상 관련 교육 이수자 우대

-업무 상 영어 Reading & Writing활용 가능자

[근무환경]

-계약기간: 12개월 (파견계약직)

-근무지:재택

-근무시간: 09:00 ~ 18:00 (주 5일 근무)

-급여:회사 내규에 따름 (업계 상위 / 경력직의 경우 별도 협의)

-복리후생: 4대 보험,연차, 생일/명절 선물,경조 휴가/각종 경조금, 우수근무자 포상 등 맨파워코리아 규정

[지원방법]

-이메일지원: Fernando.moon@manpower.co.kr

-이메일제목: IQVIA(Medical Information/재택근무)_본인성함기재

-제출서류:국/영문이력서및자기소개서 (MS Word 양식)

-담당자:문정석과장, 02-6420-0393

- 지원 마감일: 2021년 01월 31일 일요일 자정