[Janssen] IPV Case Management Sr. Specialist
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
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1. ???: IPV Case Management Sr. Specialist (Contractor)
2. ???: ?? (Janssen)
3. ???: ??? ???
4. ?? ??: Fixed-term (1 ? 6??)
[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.
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https://careers.jnj.com -> Requisition number “2406209146W” ?? -> ?? ?? ?? ?? ?, “Apply Now”
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