崗位職責(zé)：?·?????????Perform?single?case?medical?assessment,?including?the?determination?of?seriousness,?expectedness/listedness/labeledness,?and?causality?of?adverse?events?in?compliance?with?current?regulations,?internal?and?external?guidance?documents,?Standard?Operating?Procedures,?Safety?Job?Aids,?the?Argus?User?Reference?Guide?and?case?processing/coding?conventions.???·?????????Maintain?the?timely?submission?of?expedited?reports.?·?????????Support?the?achievement?of?the?Therapeutic?Area’s?case?processing?performance?timelines.??Identify?cases?that?meet?SUSAR?reporting?criteria,?prepare?the?SUSAR?narrative,?perform?risk?assessment,?initiate?the?unblinding?process?(as?appropriate),?and?make?the?report?available?for?distribution.?·??????????Identify?and?evaluate?safety?signals?based?on?individual?cases?and?cumulative?data?assessment?and?by?using?other?signal?detection?systems.?Provide?data-driven?decisions?and?communicate?these?findings?proactively?and?effectively?to?the?key?stakeholders.???·?????????Partner?with?Safety?Surveillance?and?Risk?Management?and?with?other?Worldwide?Safety?and?Regulatory?functional?groups?to?monitor?the?safety?profile?of?assigned?products.?·?????????Actively?participate?in?Risk?Management?Committees?and?other?risk?management?activities?for?assigned?therapeutic?areas.?Perform?product?safety?reviews?as?appropriate.?·?????????Provide?medical?safety?input?as?appropriate?to?Clinical?Development?Teams?regarding?expectedness/listedness/labeledness,?causality,?and?data?reconciliation.??·??????????As?appropriate,?provide?medical?safety?input,?and?review?or?draft?sections?of?response?documents?to?health?authority?inquiries.?·?????????Work?with?the?Therapeutic?Area?Head?and?Medical?Review?Head?to?proactively?and?effectively?communicate?product?safety?issues?and?proposed?solutions?to?PSSR?management?and?to?the?Office?of?the?EU?Qualified?Person.?·?????????Provide?timely?review?of?and?input?to?documents,?including?labeling,?protocols,?Investigator?Brochure,?and?licensing?agreements.???·?????????Provide?timely?input?into?product?related?milestones.????·?????????Provide?medical?input,?review?and?analysis?of?Periodic?Safety?Update?Reports,?Expert?Statements,?Risk?Management?Plans,?and?other?aggregate?reports;?where?appropriate,?draft?components?of?these?reports.??Ensure?accurate,?relevant,?and?meaningful?ICSR?data?and?insights.??·?????????Provide?medical?advice?and?insights?to?Therapeutic?Area?colleagues?to?improve?the?quality,?consistency,?accuracy,?and?clinical?relevance?of?safety?reports.?·?????????Support?PSSR?Quality?Assurance?activities,?addressing?observations?related?to?medical?assessment,?as?appropriate.?Ensure?consistency?and?quality?of?the?medical?assessment?process.?·?????????Provide?drug?safety?support?when?appropriate?to?product?acquisitions,?recalls,?and?legal?issues.??·?????????Take?responsibility?for?inspection?readiness?for?medical?assessment?activities;?support?regulatory?authority?inspections?when?needed.?·?????????Proactively?communicate?with?and?engage?Therapeutic?Area?colleagues?and?key?stakeholders?(e.g.,?Clinical?Development?Teams,?Regulatory?Affairs,?Licensing,?Manufacturing,?and?Marketing)?to?support?business?objectives?and?to?discuss?and?resolve?safety?issues.?·?????????Engage?internal?and?external?customers?with?a?sense?of?urgency?and?an?appreciation?of?their?needs?and?point?of?view.???·?????????As?an?individual?contributor,?initiate?and/or?take?a?leadership?role?in?projects/process?improvements?that?align?with?PSSR?and/or?SER?strategic?objectives.?·?????????Develop?and?maintain?comprehensive?and?current?knowledge?(e.g.,?indications,?labeling?documents,?pharmacology)?for?the?assigned?product?portfolio.?·?????????Develop?and?maintain?a?comprehensive?working?knowledge?of?current?regulations?governing?the?processing?and?reporting?of?safety?data,?Standard?Operating?Procedures,?Safety?Job?Aids,?and?case?processing/coding?conventions,?consistently?completing?curriculum?training?by?the?specified?due?dates.?·?????????Utilize?the?corporate?performance?management?process?to?manage?goal?setting?and?individual?development.?Consistently?demonstrate?Pfizer?Values?and?Leader?Behaviors.?·?????????Proactively?mentor?Therapeutic?Area?colleagues?to?foster?an?environment?of?trust,?understanding,?learning,?and?development.?·?????????Contribute?to?the?mentoring?and?on-boarding?of?new?PSSR?colleagues???任職要求：?·?????????Demonstrated?computer?literacy,?with?proficiency?in?the?use?and?management?of?safety?databases,?including?the?Pfizer?Global?Safety?Database,?Argus?Safety,?and?MS?Window,?Excel,?Word?and?Outlook?·?????????Ability?to?achieve?personal?objectives?while?meeting?departmental?standards?of?performance?·?????????Fluency?in?oral?and?written?English;?knowledge?of?additional?language(s)?an?advantage?·?????????Experience?and?skill?with?medical?writing?an?advantage?·?????????Medical?Degree?from?an?accredited?institution?·?????????One?to?two?years?of?experience?as?an?MD?in?clinical?practice?·?????????One?to?two?years?of?relevant?experience?in?pharmacovigilance,?clinical?research?or?related?field??·?????????Pharmaceutical?industry?experience?preferred?·?????????Working?knowledge?of?international?regulations?and?guidance?documents?as?related?to?worldwide?reporting?requirements,?preparation?of?clinical?trial?safety?assessments,?and?regulatory?submissions?including?the?preparation?of?aggregate?reports