崗位職責(zé)：
1.?Prepares?the?respective?submission?documents?to?Health?Authorities
2.?Supervision?of?proper?flow?of?confirmations?of?receipt?of?documentation?sent?to?the?Health?Authorities.
3.?Preparation?and?everyday?distribution?of?respective?Patient?Safety?documents.
4.?Participation?in?the?verification?process?of?data?correctness?in?the?global?safety?database.
5.?Verification?of?correctness?and?compliance?of?documentation?sent?to?Patient?Safety?Department
6.?Preparation?of?the?Patient?Safety?training?materials?(incl.?confirmations)?and?logistic?organization?of?these?trainings
·?Editing?(where?required?and?as?per?request?from?Patient?Safety?Member)?training?materials
·?Preparation?of?confirmations,?certificates,?printing?of?training?materials?for?participants
7.?Archiving?all?safety?documentation?as?per?respective?policies,?guidance?and?procedures.
8.?Verification?and?update?of?respective?PS?archiving?system?(incl.?review,?update,?management)
9.?Monitoring?of?the?compliance?with?support?of?PS?Associate
10.?Manage?collection,?processing,?documentation,?reporting?and?follow-up?of?all?adverse?events?reports?for?all?Novartis?group?products?from?clinical?trials,?non-interventional?studies,?Patient?Oriented?Programs,?literature,?Spontaneous?Reports,?etc.
11.?Record?and?track?receipts,?submissions?and?distributions?of?SAEs,?SRs,?Suspected?Unexpected?Serious?Adverse?Reaction?(SUSAR).
12.?Manage?reporting/submission/distribution?of?safety?reports/updates/information?(e.g.?SAE,?SR)?to?Local?Health?Authorities?(LHA)?and/or?clinical?operations.
13.?Work?with?other?local/global?PS?associates?to?ensure?accurate?evaluation?of?safety?data.
14.?Interact?and?exchange?relevant?safety?information?with?LHA,?PS?associates,?other?functional?groups?and?third?party?contractor,?if?applicable.
15.?Survey?and?monitor?national?pharmacovigilance?regulations?and?provide?update?to?global?PS?organization.
16.?Support?in?developing,?updating?and?implementing?local?procedures?to?ensure?compliance?with?PS?global?procedures?and?national?requirements.
17.?Input,?review?and?approval?of?program?proposals?for?language,?content?and?establishment?of?necessary?controls?on?collection?and?reporting?of?adverse?event?information.
18.?Perform?reconciliation?with?other?departments?(e.g.?Medical?Information,?Quality?Assurance?and?third?party?contractor,?if?applicable)?for?potential?AEs?resulting?from?medical?inquiries,?quality?related?complaints?and?other?sources.
19.?Management?and?maintenance?of?all?relevant?PS?databases.
20.?Prepare?and?submit?KPI?reports?on?compliance?in?a?timely?manner?including?identification?of?root?cause(s)?for?late?reporting?to?LHA,?development?and?implementation?of?corrective?action(s)?as?needed.
*delete?when?not?needed/not?appropriate,?or?modify?as?per?local?activities.
任職要求：
·?Fluent?in?both?written?and?spoken??English
·?Fluent?in?both?written?and?spoken??local?language
·?Experience??on?similar?position?in?drug?safety?or?drug?registration?or?clinical?research??department?would?be?an?additional?asset.
·?Proven??ability?to?work?in?cross-functional?teams
·?Computer??skills?(e.g.?Excel,?Word,?Power?Point)?and?ability?to?learn?new?systems??quickly.