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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.
1. 포지션 : Pharmacovigilance Specialist
2. 계열사 : 한국얀센 (Janssen)
3. 근무지 : 서울시 용산구
Ensure that systems and processes are availablefor collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources : spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
1) Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
2) Oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.
g. patient support programs, market research surveys, internet sites), as applicable.
3) Assure that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
4) Maintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH).
5) Identify local Medical / Scientific Literature not available to global, review for AEs and report as required per literature reporting criteria.
6) Involvement in implementation of Risk Management Plan, if required. Oversight and tracking of the implementation of core additional risk minimization activities
7) Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
safety management and reporting)
1) Degree in health / science / medical related field (Pharmacist preferred)
2) At least 1-2 years of PV related experience (e.g. CRA, MIS, Hospital Pharmacist)
3) English proficiency (oral and written)
4) Strong collaboration and interpersonal skills
5) Strategic thinking
6) Results oriented and able to independently create and deliver
7) Strong communication and presentation skills
8) Displays initiative
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Requisition number 1805650633W 검색 ->
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