药物警戒/药物安全（Pharmacovigilance）

Responsibility:
• Responsible for day-to-day adverse experience case management withinthe country(ies) covere******** the country operation including caseintake an********-up activities in accordance with Global Safetyproce******** the review of local literature as per client’s procedurean******** regulat******** an******** authority submissions of cases inaccordance with Global Safety procedures an******** authorityrequirements.
• Responsible for aggregate safety report submissions in thecountry(ies) in accordance with Global Safety procedures an********authority requirements.
• Responsible for the reconciliation of adverse events reportsreceive******** other client’s operating units (e.g., Designate********of Contact, Medical Informat******** etc.) an******** partners, asapplicable Responsible for the f******** storage an******** ofsafety-relate******** in accordance with client’s policies an********requirements.
• Serve as the local Deputy Qualifie******** for PV (QPPV) / deputylocal responsible PV person for the country(ies) when delegate********PV Country Lead.
• Serve as back-up in the absence of the PV Country Lea******** ensurebusiness continuity.
• Responsible for being compliant with local PV regulat******** clientpolicies an******** an******** Safety procedures at the country level.
• Participate in individual case safety report compliance activitiesan******** the necessary corrective actions locally for the latereporting within the country(ies) covere******** the country operation.
• Assist in preparation for audi******** for their country/territoriesan******** participate in the audit and/or inspection. Identifyan******** potential safety issues to PV Country Lead. Assist in thedelivery of training to PV staff an******** facing non-PV staff (e.g.,Sales Reps, Medical Informat******** etc.) an******** / vendors /business partners in the country(ies) within scope.
• Complete an******** require******** training within therequire********. Perform other activities as requeste******** the PVCountry Lead.
Education:
• The incumbent must have a health, life sc******** or medical sciencedegree or equivalent by education / experience.
Experience:
• Fresh graduates are welcomed.
• 0.5-1 year of pharmaceutical industry experience preferred, especiallyexperience as PV.
• He/she must have an awareness of Pharmacovigilance regulations withinhi******** assigne********(ies).
• The PV Specialist is expecte******** have strong communicationan******** management sk******** an******** the ability to workindependently with minimal supervision.

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