Organizational?Relationship(s)?including?to?whom?the?position?reports?(JD?Job?Title):Reports?to?Therapeutic?Area?Team?Lead向治療領域小組負責人匯報Position?PurposeReview,?preparation,?and?completion?of?reports?of?adverse?drug?experiences,?to?determine?the?safety?profile?of?Pfizer’s?products?and?to?meet?regulatory?requirements.審核,準備,完成藥物不良經(jīng)歷報告,幫助認識輝瑞產(chǎn)品的安全面貌,并符合法規(guī)報告要求。Primary?Responsibilities?·?Provide?professional?evaluation?to?Individual?Case?Safety?Report?(ICSR)?in?Pfizer?Safety?Database,?including?but?not?limited?the?activities?as?follows.在輝瑞安全數(shù)據(jù)庫中,對ICSR做專業(yè)評估。包括但不僅限于以下內(nèi)容。-?Identify?reportable?cases,?evaluate?cases?in?appropriate?prioritization,?and?meet?reporting?timeline明確需要提交的報告,合理安排優(yōu)先秩序?qū)蟾孢M行評估,符合報告時限。-?Review,?rank,?verify,?process?and?document:?event?terms;?case?classifications?(validity,?seriousness,?expectedness/listedness/labeledness);?special?scenarios;?product?complaint?information;?and?etc.對下述內(nèi)容進行審核,排序,核對,評估和存檔:事件,報告類別(有效性,嚴重性,已知性),特殊情況,產(chǎn)品投訴信息,等等。-?Write?and?edit?the?case?narrative.撰寫和編輯報告描述?!?Consistently?apply?regulatory?requirements?and?Pfizer?policies.完全遵守法規(guī)要求和輝瑞政策。Technical?Skill?Requirements·?Experience?in?pharmacovigilance,?in?clinical?care,?or?in?clinical?or?scientific?research?is?an?advantage?but?not?a?requirement.具有以下經(jīng)驗者優(yōu)先考慮:藥物警戒,臨床實踐,臨床或科學性研究。但不是必須。·?Demonstrated?computer?literacy,?particularly?in?the?use?and?management?of?relational?databases.熟練運用計算機,特別是有使用相關數(shù)據(jù)庫經(jīng)驗者。?·?Excellent?oral?and?written?communication?skills.良好的口頭和書面溝通能力?!?Fluency?in?spoken?and?written?English.流利英語口語和書寫。Qualifications?(i.e.,?preferred?education,?experience,?attributes)·?Bachelor’s?degree?in?a?science-related?field,?pharmacy,?nursing,?or?equivalent;?healthcare?professional?qualification?preferred.科學相關領域本科及以上,藥學,護理,或同等學歷;醫(yī)務工作資質(zhì)者優(yōu)先考慮?!?Ability,?with?supervision,?to?solve?routine?problems?and?to?surface?issues?constructively.?能在指導下解決日常問題,并且建設性面對難題?!?Ability?to?make?basic?decisions?with?an?understanding?of?the?consequences.?能在理解事情結果的情況下獨立做決定