KNOWLEDGE,?SKILL,?FORMAL?EDUCATION?&?EXPERIENCE?REQUIREMENTSA.?Knowledge?And?Skills:Medical?and?Scientific?expertise.High?level?of?autonomy,?motivation,?good?communication?skills?as?well?as?team?playerAutonomous,?proactive,?able?to?drive?an?activity?until?final?deliverableSelf-motivated?&?results?oriented?with?attention?to?detailQuality?focused?and?well?organizedB.?Formal?Education?And?Experience?Required:Medical?educational?background?with?M.D.?or?Master?or?PhD?degreePhysician?with?clinical?practice?experience?in?hospitals?at?least?1?yearPrior?to?consider?previous?medical?validation/review?experience?in?Clinical?Research?and/orClinical?DrugDevelopment?(e.g.,?at?least?1?year?within?pharma?industry?or?CRO)Knowledge?in?ICH,?GCPFluent?in?English?(spoken?and?written)C.?Knowledge?And?Skills?Desirable?But?Not?Essential:Technical:?knowledge?in?reporting?tools?and?technicsPRINCIPAL?DUTIES?AND?RESPONSIBILITIES?1.?Conduct?medical?validation/review?tasks?directly2.?Conduct?medical?validation/review?according?to?compound?safety?profile,?study?population?characteristics,study?design?and?efficacy?criteria3.?Review/comment/provide?input?at?Medical?Validation?KOM,?Medical?review?plan?KOM.?Participate?in?updateof?MVP/MRP?base?on?new?information?during?course?of?study?conduct4.?Set?up?/schedule?medical?review?resolution?meetings?with?CSDs?(GSOs?ad?hoc),?Schedule?CIOMS/PPreview?reconciliation?meetings?with?CSDs?(CTOMs?or?CMEs?ad?hoc)5.?Working?with?Team?Leader,?taking?into?account?CSDs’?perspective?on?the?task?allocated.?Define?prioritiesfor?the?allocated?tasks6.?Interact?with?Team?Leader?regularly?on?tasks?advancement?and?completion,?difficulties?encountered,?andpotential?delays7.?Define?timelines?for?completion?of?each?task,?in?coordination?with?team?Leader?and?CSDs8.?Proactively?communicate?with?other?functions?(eg?TO,?GPE,?CSU,?CDOC,?TIM?(BICC)?and?so?on)?toresolve?safety?data?issues?timely?and?effectively
