職位描述：

Areyoupassionateaboutservingasthesafetyreportinglead?TheDSAwillprepare,performqualitychecksof,andsubmitexpeditedandperiodicreportsforalltypesofsafetyeventsandothermedically-relatedprojectinformationundermentorshipofaDrugSafetyCoordinator.

SeniorDrugSafetyAssociaterolewithinICON:

TheSeniorDrugSafetyAssociatepreparesandperformsqualitychecksofregulatorydocumentationpacketsandcoordinatesthetimelycompletionandsubmissionofrequiredreportstoHealthAuthorities,EthicCommittees,PrincipalInvestigatorsandthirdparties.Youwillalsoensurecompliancewithregulatoryreportingrequirementsforsafetyreporting(pre-marketing,post-marketing,deviceanddrug)and/orothermedicallyrelatedinformationperassignedtasksandprojectspecificprocedures.

?Recognize,exemplifyandenforcetoICON'svalueswhichcentersaroundourdedicationtoPeople,ClientsandPerformance.

?Asamemberofstaff,theemployeeisexpectedtoembraceandcontributetoourcultureofprocessimprovementwithafocusonstreamliningourprocessesaddingvaluetoourbusinessandmeetingclientneeds.

?Travel(uptoapproximately15%)domesticand/orinternationalasapplicable

?CompletealldepartmentalprojectactivitiesaccuratelyinaccordancewithICONSOPs,StudySpecificProcedures,regulatoryrequirements,andSponsorsprocesses

?Reviewandprocessseriousadverseevents,spontaneouslyreportedadversereactionsand/orothermedicallyrelatedinformationperassignedtasksandstudyspecificprocedures

?Provideinputandreviewrelevantsafetytrackingsystemsforaccuracyandqualityandassistwithmaintainingprojectfiles

?Performsafetyreviewofclinicalanddiagnosticdata

?Liaisewithinvestigationalsite,reporter,and/orSponsorasnecessaryregardingsafetyissues

?Attendprojectteammeetingsandteleconferencesasrequired

?ServearesourceforinvestigationalsitesandICONpersonnelonsafety-relatedissues

?LiaisewithSponsorandattendSponsormeetings,asrequired

?LiaisewithICONprojectmanager,andothergroups,asappropriate

?IdentifyoutofscopeactivitiesinconjunctionwiththeMSSFunctionalLeadand/orClinicalProjectManager

?Train/mentornewlyhiredDSAstaff,asrequested

?Assistwithcoordinationofinterdepartmentalactivities(e.g.listingreview,qualitycontrol,qualityassurance(audits),miscellaneousprojectactivities)

?Generatestudyspecificproceduresforcontracteddepartmentalservices

?Assistmanagementwithweeklyandmonthlyprojectstatusreports

?Assistwithgenerationofregulatoryreportsasnecessarytoensureregulatorycompliance.

?Conductsafetypresentationsforstart-upmeetings,Investigatormeetingsandothermeetings

?ServeasleadDSAonall(includingglobal)medicalorsafetyprojectsasassigned

?AssisttheMSSFunctionalLead(e.g.MedicalMonitor)independently

?Performotheractivitiesasidentifiedandrequestedbymanagement

Tosucceedyouwillneed:

Weareseekingcandidateswithamedical/sciencebackgroundwithabachelor’sdegree.Minimumof3-4yearsrelatedexperienceinPharmacovigilance.TobesuccessfulyouwillbeexpectedtobeproficientinMicrosoftOfficeskills(Word,Excel,andAccess).Havegoodcommunicationskills,befluentinwrittenandverbalEnglish,detail-orientedandhavetheabilitytoworkeffectivelywithinateamenvironment.

BenefitsofworkingatICON:

Inadditiontopartneringwiththetoppharmaceuticalandbiotechcompaniesintheworldweofferastrongbenefitspackagethatincludesacomprehensivehealthplan,retirementplans,competitivepay,bonusplans,vacation,andotherincentives.

ICONhasastrongreputationinourapproachestoclinicaldevelopment.Weapplyscientificandoperationalperfectionacrossallphasesofclinicaltrialoutsourcingservicesforourclients.WeworkwithtoppharmaceuticalorganizationsonemergingtherapeuticareaswhichincludebutarenotlimitedtoOncology,Vaccines,CNS,CardiovascularandPain.Wearepresentlyinover40countrieswithover80officesworldwideandover10Kemployeesglobally.

篇2:藥物分析專員崗位職責

藥物分析專員浙江尖峰藥業有限公司浙江尖峰藥業有限公司,尖峰藥業崗位職責:

從事新藥開發質量分析研究工作,具體如下:

1、負責新藥穩定性考察樣品的保存及送檢工作,及時追蹤質量情況,做好質量分析,定期書面報告經理;

2、負責制定在研品種(包括產品、中間產品、原輔料、內包裝材料)質量標準和檢驗標準操作程序,及之前的質量研究工作;

3、按規定內容及時逐項填寫檢驗記錄,記載檢驗過程的一切原始數據和現象,包括鑒別試驗、測試數據、演算過程、判定結論、化驗人、復核人簽章等,保證記錄的正確性、嚴密性、全面性和可靠性;

4、負責產品試制工作中的藥品及中間產品(包括判定反應終點)的檢測工作,及時完成各項檢驗任務,做好信息溝通,并在規定工作時日內出具檢驗報告;

5、負責在研品種藥學研究工作中質量研究及穩定性研究工作;

6、做好各種檢驗儀器、設備的維護保養工作,并作好儀器使用記錄。做好?器、量器及要求強制檢定設備的檢定工作;

7、負責與中控室、中心化驗室聯系與協作,完成樣品檢驗工作,認真及時完成其它臨時安排的檢驗或復核任務;

8、負責(專人)配制分析用的各種試液、標準溶液、滴定液的標化和復核,并按規定定期復標。

崗位要求:

1、年齡35周歲以下,本科以上學歷,藥物分析、分析化學、儀器分析等相關專業畢業;

2、熟悉常規儀器分析,有相關工作經驗者優先;

3、身體條件符合藥品企業從業人員健康標準,工作認真、堅持原則,責任心強有較強的工作能力。

篇3:藥物分析研究專員崗位職責任職要求

藥物分析研究專員崗位職責

1、負責氣相色譜儀、氣相質譜儀的日常使用、維護;

2、負責氣相色譜儀、氣相質譜儀相關研究的SOP撰寫;

3、負責雜質檢測的方法開發和驗證工作;

4、負責按照相關SOP對雜質進行檢測,并出具相應的驗證和分析檢測報告;

5、負責采用氣相色譜儀、氣相質譜儀對生物樣本中的藥物濃度進行檢測,并對方法進行驗證。

任職條件:

1、藥物分析及相關專業;

2、本科要求具有3年以上具有檢測相關工作經歷;碩士要求具有1年以上具有檢測相關工作經歷;

3、熟練掌握GC、GC-MS的原理及使用和維護,能夠分析和排除常見故障;

4、熟悉藥物分析的相關法律法規,了解氣相檢測相關的產品標準、檢測標準;

5、具備良好的職業道德素養,責任心強、善于溝通和協作。