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채용공고

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Sr. Associate PV 경력직 채용
채용구분 경력 고용형태 정규직
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채용부문 Sr. Associate PV
상세내역
  • The Sr. Associate PV is responsible for:
  • ICSR Case intake and local process
  • • Manage contacts of external and internal customers in matters relating to drug safety, ensuring that a professional, approachable and informative impression is given at all times.
  • • Process spontaneous product safety information from various sources (e.g, medical information, competent authorities, literature) according to relevant processes and standards, using the local case tracking system.
  • • Process clinical trial, post authorization safety study product safety information according to the relevant processes and standards.
  • • Perform local literature review, if applicable.
  • • Ensure correct use and entry of data in the PV case tracking system
  • • Ensure timelines are met for each activity to ensure compliance, and monitoring at an affiliate level.
  • Local PV Quality Management System
  • • Maintain appropriate logs and databases as necessary for optimal functioning and oversight of the local PV department
  • • Support with writing and updating of local PV processes and standards.
  • • Support the PV affiliate lead/Drug Safety Officer (DSO) with internal and external PV-related correspondence.
  • • Execute routine reconciliations of various databases and with PV partners.
  • • Perform routine quality checks on the Out of hours availability at the affiliate according to relevant processes and standards.
  • • Participate in the development of safety monitoring and reporting plans for local clinical trials.
  • • Support the implementation of PV Agreements and PV contracts with local vendors
  • • Ensure correct filing (electronically and hard copy) and archiving of related documents according to Good Documentation Practices
  • • Update and maintain local Quality Documents (QDs) as required.
  • • Take part in special PV projects as and when needed upon assignment by PV affiliate Lead/DSO.
  • • May represent the local PV department in inspections and audits. Support with PV health authority inspections and audits.
  • • Support in monitoring local case submission compliance and take the necessary corrective and/or preventive actions locally for late reporting.
  • • Support in reporting compliance and other PV-related information as requested by PV Affiliate Mangement Function.
  • • Follow the business continuity plan for eg, system failure and disasters in relation to PV activities.
  • • Participate in the 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate.
  • • Submit aggregate safety reports in Korea.
  • • Assist in developing and implementing K-RMP
  • People and Organization Management
  • • Guides junior colleagues and/or oversees and controls local PV activities
  • • Performs local PV training as needed
  • • Responsible for the development and maintenance of effective collaborations with peers and internal PV key stakeholders and functions as well as relevant other stakeholders::
  • • With Health care professionals and consumers using Astellas’ products.
  • • With PV Affiliate Lead/DSO or delegate (line manager), other local interfaces e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Quality Assurance Marketing, Sales, Ethics and Compliance and other business functions.
  • • With PV Affiliate Management Team Members
지원자격
  • • Experience on PV or pharmacy related job for over 4 years
  • • Previous working experience from pharmacovigilance/clinical trials activities is preferred.
  • • Degree level in Pharmacy or an equivalent healthcare area
  • • Pharmacist license is preferred
  • • Ability to present accurate messages in both written and spoken English from complex information
제출서류
  • [기본]
    ▸ 자격증 사본(해당자에 한함)
  • ▸ 국가보훈대상자는 취업지원 대상자 증명서 제출
  • ▸ 장애인 대상자는 장애인 증명서 제출
  • [필수] ▸ 최종학교 졸업증명서 및 성적 증명서
  • [필수] ▸ 이력서에 기입 된 재직(경력)증명서 전체
  • [필수] ▸ 영문 CV

※제출서류는 지원서 제출시 첨부파일로 제출

채용절차 1차 (서류전형) → 2차(면접)→ 3차(최종면접) → 건강검진 → 최종합격통보 → 채용
접수방법 당사 홈페이지에서 온라인 입사지원 https://recruit.astellas.co.kr
서류접수기간 ~2020.08.14(금) 23:00까지
문의처
주의사항
  • 마감일은 기업의 사정으로 인해 예고없이 변경될 수 있습니다.
    반드시 마감일 전 넉넉하게 시간을 두고 입사지원 해주십시오.
  • 기재사실이 허위임이 판명될 경우에는 합격이 취소됩니다.
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