국가임상시험지원재단

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

- 포지션: International Pharmacovigilance Case Management Sr. Specialist
- 근무지: 서울시 용산구
- 근무형태: 정규직 (Regular)

[Summary]
The International Pharmacovigilance (IPV) Senior Case Management Specialist is to;
1. 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.
2. The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the APAC Region (centralized case management) are carried out in a timely manner.

[Responsibilities]
As applicable, the responsibilities described below may account for cross-country collaborations
1. INBOUND & OUTBOUND ICSR CASE MANAGEMENT
- Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
- Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
- Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
- Data entry for complex cases
- Performing follow-up for requesting additional information from multiple sources.
- Assist in the quality review of data captured in the GIRS 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 respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
- Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
- Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).

2. AGGREGATE REPORTING
- Independently and with minimal supervision, ensure timely submission of aggregate safety reports (e.g. DSUR, PSUR etc. applicable) to applicable health authorities, in collaboration with local medical safety input.

3. 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.
- Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional

4. AUDIT / INSPECTION PREPARATION AND SUPPORT
- Represent IPV Case management or support the LSO, in matters pertaining to audit or inspection preparation or conduct.

5. OTHER ACTIVITIES
- Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
- Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).
- Periodic reconciliation activities
- Support IPV Case Management Team Lead / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required.
- Lead or support case management related innovation roll-out, in collaboration with the IPV Case Management Regional and Team leads
- Lead or support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
- Write or review ICSR related procedural documents and local memo implementation as applicable.
- Act as a mentor to junior staff and quality checking their work
- Lead or support critical project works

[Requirements]
1. Strong medical background (A degree in life, health or pharmaceutical sciences is preferred e.g. Pharmacist, Medical doctor, Biologist).
2. Sound knowledge of general medicine, or pharmacy, or clinical practice; proficiency in Medical terminology (local languages).
3. Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
4. Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
5. Ability to prioritize and work to strict timelines daily
6. Excellent verbal and written communication skills
7. Fluency in local (if applicable) and English language required
8. Ability to negotiate and communicate with internal and external customers
9. Knowledge and understanding of key legislation applicable to pharmacovigilance within
10. Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable

[지원 방법]
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[서류 마감일]
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