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- 职位介绍
- Major tasks and responsibilities of position •Assures compliance of local regulation and company's QSDs of responsible local PV safety management activities under the supervision of senior safety management officer and safety management manager. •Prepares/submits safety data/report with PV expertise for supporting the drug registration, labelling management, PSUR and other product life cycle management under the supervision of senior safety management officer and safety management manager. •Handles SAE report received from clinical trials. •Assists safety relevant issues handling according to the local QSD for the responsible products. •Reviews the PV relevant documents to ensure the PV compliance for the responsible products under the supervision of senior safety management officer and safety management manager. •Reviews the local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. market research, Active-Online-Listening) for the responsible products to ensure Pharmacovigilance principles are applied in the interaction with patients. Accountable for program initiation, monitoring of the programs to ensure adherence to the PV agreements, supporting to provide PV training to all internal and external program staff prior to program initiation and on ongoing basis. •Attend local SMT meeting and involves in the collaboration with Global pharmacovigilance on all Risk Management Plan activities. •Reviews local relevant medical literature according with the PV standard operations and procedures. •Assists the complex safety queries answering with other relevant functions for the responsible products. •Be responsible to answer the 24 hours PV emergency hotline by turns. •As a project team member, assists or participants in the assigned external functional projects led by the project leader. Qualifications •The applicable Competency Model for this position focus on plans & aligns, manage complexity, collaboration and drives results • Planning and prioritizing work to meet commitments aligned with organizational goals. • Ensuring accountability and consistently achieving results, even under tough circumstances. • Building partnerships and working collaboratively with others to meet shared objectives • Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems •University degree in medicine, pharmacy, natural sciences or an equivalent qualification •PV relevant working experience 2-3 years •Good command of the English language •Team player •Good communication skills •Ideally knowledgeable in Pharmacovigilance relevant regulations •Ability to take personal responsibility and accountability
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