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[외국계 제약사] PV APAC Regional Coordinator(Pharmacovigilance)_1year contract

Posted: 2 days ago

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Job Description

[외국계 제약사] PV APAC Regional Coordinator_1year contract (육아휴직 대체)Role DescriptionResponsible for management of the formulation, review, update and compliance of Pharmacovigilance Agreements (PVAs) for potential and active External Party activitiesManages all workflows related to PVAs in APAC region in collaboration with the regional business, Patient Safety and other functions Support development and maintenance of standard PVA templates for use at global and local level. Ensure all safety information at a local level is captured in the Global Pharmacovigilance safety database and submitted to regulatory authorities as per regulatory requirements,Qualifications • Minimum of 2 years’ experience in the pharmaceutical industry in pharmacovigilance (preferred) and/or related field required. (e.g. regulatory or medical/clinical affairs, legal, quality). Strong understanding of pharmacovigilance principles, regulatory guidelines, and compliance requirementsExcellent communication and collaboration skills for engaging with stakeholders and regulatory authorities across the APAC regionProficiency in English and additional knowledge of a regional language is advantageousMust hold a Pharmacist License

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