PV Officer (15Months)
1. Responsible for data entry from all reporting sources in the Local Affiliate Module (LAM) of the Global Safety Database (Argus) where applicable, as well as perform quality control (QC) of Individual Case Safety Reports (ICSRs), entered in LAM in accordance with PV LAM QC process.
2. Liaises with the Local Quality Representative (LQR) in relation to AE reports associated with Product Technical Complaint (PTC) and aligns on actions.
3. Responsible for case receipt and transfer to Argus where applicable. Identifies cases where missing or unclear information is provided and performs clarification as needed with reporter.
4. Performs follow-up activities of ICSRs in a timely manner.
5. Responsible for reconciliation of cases with internal functions and external partners.
6. Performs the submission of the ICSRs to HA in accordance with the national regulations.
7. Monitoring of local PV regulation and QSD management and maintenance of the local PSMF (Pharmacovigilance System Master File).
8. Assists with local PV CAPA management activities. The PVO is also expected to overview PV quality of various programs and projects initiated by internal stakeholders.
9. Contributes to audits, inspections and contract management.
10. Is involved in the preparation of the PV training given to the local organization (schedule, training material, organization). When indicated by the PVCH, the PVO can completely take over the PV training.
11. Conducts the local literature search for AEs as well as the routine testing of PV systems.
12. Contributes to the handling and generation of aggregate reports and SUSAR/line listings reporting to National Competent Authority (NCA), relevant ethics committees and investigators in the country, where applicable.
13. Participates in local safety issue management activities as requested by the PVCH.
14. The PVO can be delegated by the PVCH to be involved in Risk Management Plan activities, which may involve developing and implementing additional local risk minimization measures, with other stakeholders, where applicable.
15. The PVO supports the PVCH in the provision of safety input into clinical, medical and commercial studies and projects.
[Qualifications / Requirement]
- Life science graduate (preferably health-care professional)
- Experience in pharmacovigilance activities (ideally 2 or more years)
- Good knowledge of medical terminology
- Detail-minded and task-oriented person
- Ability to adhere to procedures
- Ability to communicate orally and in writing in the local language and English
- Excellent administrative skills
- Good computer knowledge
- Strong sense of responsibility and conscientiousness, priority setting, organizing
- Stress resistance and ability to comply with strict deadlines
근무 형태: 계약직
근무 요일/시간: 주 5일(월~금)
근무 지역: 서울 영등포구 여의도동
급여: 회사내규에 따름
전화: 02 - 829 - 6511
- 면접은 서류전형 합격자에 한해 개별통지 합니다
- 국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대합니다
- 남자는 병역필 또는 면제자로 해외출장에 결격사유가 없는 자를 모집합니다
- 제출하신 서류는 일체 반환하지 않습니다.
- 입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.
- 신체적 조건과 출신 지역, 혼인 여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직업, 재산과 관련된 정보는 지원서류에 포함하지 마십시오.
(단, 바이엘코리아에 재직 중인 가족이 있을 경우, 회사가 공정한 채용을 위한 조치를 취할 수 있도록 입사지원서를 통해 사전에 고지해 주시기 바랍니다.)