Job Title: PV Specailist (PV : Pharmacovigilance) Department : PV Employment Type : 1-year contract Division : MRL Reports to (Title) : Country PV Lead # of Subordinates : 0 Job Objective Essential functions & main objective of the job The Pharmacovigilance (PV) Specialist reports to the Pharmacovigilance Country Lead and is responsible for case management activities for Postmarketing and Investigational products in the country/territory. He/She complies with PV processes and regulations, and Merck policies and procedures for his/her country operation. This applies to all relevant safety information. The PV Specialist is qualified to function independently in the processing of Adverse Events. Main Roles & Responsibilities Primary responsibilities in order of importance 약물감시 업무(의약품 안전성 정보수집) n Compliance Responsibilities - Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry center or contractual partners - Conduct follow-up as required - Conduct reconciliation of adverse events reports received from other Merck operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable - Submit, as applicable, spontaneous and solicited / clinical trial individual case safety reports (ICSRs) from their country/territories to the local Health Authorities - File, store, and archive safety-related data - May serve as back-up coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity - May serve as the local Deputy Qualified Person for PV for their country in the absence of the local Qualified Person for PV when delegated - Comply with PV regulations and Global Safety policies/procedures and when needed propose corrective action - Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory - 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 - Assist in delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors - Complete and document required PV training within required timelines - Perform other activities as requested by the Pharmacovigilance Country Lead Ensure local Literature searches for Adverse Events are conducted Required Competencies/Qualifications Specific skill levels & required Merck Leadership Behaviors n Functional Knowledge : PV Intelligence (PV industry code, system & practices), local regulatory competency (inclouding GCP concepts) n Skills : Computer skills for global system/interface, Prioritizing, Planning, Accountability, communication, and problem-solving skills, Interpersonal Savvy n Leadership Behaviors : Customer Focus, Foster Collaboration, Ethics & Integrity Minimum Level of Education r High School r Junior College r 4 – Preferred Major/Area of Study: 약학과 졸업자 Minimum Level of Experience r Less than 1 Year r 1-3 Years r 4 – 6 Years r 7 – 10 Years r 11 – 15 Years r Over 15 Years Special Area of Work Experience: Pharmacovigilence Required English Proficiency r Working Fluent r Working Confident r Working Conversational r Basic Working Relationship - Key working relationships r Internal : r External : How to apply 모집기한 : ~ 2011/12/19(월) 18:00 까지 지원서류 : 이력서 및 자기소개서, 제목은 "Contract _ PV Specialist_ 이름_ 이력서(혹은 자소소)" 지원방법 : 이메일 접수 (KR_RECRUIT@MERCK.COM 관련문의 : KR_RECRUIT@MERCK.COM Posting Period ~ December 19(Monday) 18:00
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