[Janssen] IPV Case Management Sr. Specialist

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1. 포지션: IPV Case Management Sr. Specialist (Contractor)

2. 계열사: 얀센 (Janssen)

3. 근무지: 서울시 용산구

4. 근무 형태: Fixed-term (1 년 6개월)

[Primary responsibility]

The International Pharmacovigilance (IPV) Case Management Senior Specialist is to

• Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.

• The role holder may be expected to support and ensure case management and related activities are carried out in a timely manner.

INBOUND & OUTBOUND ICSR CASE MANAGEMENT AND OVERSIGHT

• Ensure that local processes, procedures and systems are in place for the collection, review, inbound reporting, tracking, submission to HA and reconciliations of AEs, AE/PQCs, and special reporting situations obtained through all potential sources (e.g. spontaneous, clinical trials, data generation activities, literature etc.)

• Manage and maintain active involvement in day-to-day PV activities as applicable.

• Receipt, assessment and processing of incoming safety information from multiple sources

• Provision of safety information exchange, acknowledgements to business partners/Global Medical Safety within the internal and contractual timelines.

• Performing follow-up for requesting additional information from multiple sources.

• Assist in the quality review of data captured in the Global Safety Database as applicable.

• Verify and ensure translation of safety information, if applicable.

• Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to Health Authorities (HAs) / Business Partners (BPs), as applicable.

• Enable mechanisms to support the oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner, provide input on vendor oversight process

• HA query handling related to ICSRs.

AGGREGATE REPORTING

• Plan and ensure timely submission of aggregate safety reports (e.g., DSUR, etc.) to H ealth A uthorities and ensure compliance oversight requirements are met.

• Provide local data as required to support the preparation of local aggregate report

COMPLIANCE MONITORING

• Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.

• Assist with reviewing new/revised PV regulations, evaluation of the impact on local processes and notification to relevant functions, as required

AUDIT / INSPECTION PREPARATION AND SUPPORT

• Ensure audit/inspection readiness with regards to ICSR management activities and support Local Safety Unit in matters pertaining to audit or inspection preparation or conduct.

[Requirement]

ESSENTIONAL KNOWLEDGE & SKILLS

• Sound knowledge of general medicine, or pharmacy, or clinical practice; proficiency in medical terminology (local languages).

• Familiarity with ICSR related global, regional and local PV procedural documents as applicable.

• Computer literate with expert knowledge of the global system for ICSR

• Ability to prioritize and work to strict timelines daily

• Excellent verbal and written communication skills

• Fluency in Korean and English language required

• Ability to negotiate and communicate with internal and external customers

• Knowledge and understanding of key legislation applicable to pharmacovigilance

• Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable

QUALIFICATIONS

• Education: A Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider

• Experiences: 3~5+ years of previous experience on Pharmacovigilance is desired

• A degree in life, health or pharmaceutical sciences is preferred e.g. Pharmacist, Biologist.

[JD 확인 및 지원 방법]

https://careers.jnj.com -> Requisition number "2406209146W" 검색 -> 해당 모집 공고 클릭 후, "Apply Now"

[ 제출 서류]

영문 자유 양식의 이력서/ 경력기술서/ 자기소개서

[ 서류 마감일]

채용시 마감

[ 유의사항]

• 국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.

• 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.

• 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.

• 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.

https://www.careers.jnj.com

Qualifications

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