본사위치 : Kenilworth, NJ, United States.
•Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global PV procedures, the review of local literature as per MSD’s procedure and country regulations, and health authority submissions of cases in accordance with Global PV procedures and health authority requirements.
•Responsible for aggregate safety report submissions in the country(ies) in accordance with Global PV procedures and health authority requirements.
•Responsible for the reconciliation of adverse events reports received from other MSD operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
•Responsible for the filing, storage and archiving of safety-related data in accordance with MSD’s policies and local requirements.
•Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
•Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
•Identify and communicate potential safety issues to PV Country Lead.
•Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
•Complete and document required PV training within the required timelines.
•Author the PMS protocol.
•Participate as a core member for RMP and conduct the activities assigned to the Global PV.
•Manage the contract related activities.
•Background requirement: Health, life science or medical science degree (pharmacist is preferred)
•Minimum 1 years of pharmaceutical industry experience (2-3 years of PV experience is preferred)
•Functional Knowledge: Awareness of pharmacovigilance concepts, principles, practice & standards, knowledge of pharmacovigilance regulation and GCP
•Skills: excellent written & spoken English, communication skill, time management skill, sense of urgency, compliance mindset & computer skill
MSD, known as Merck in the United States and Canada, is a global healthcare company with a rich history of discovery and innovation. Throughout our 125 history, our researchers have helped to find new ways to treat and prevent illness in people and animals around the world. We've done great things in the past. Today, we're doing great things for the future. This is site is intended for audiences outside the United States and Canada.
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