Quality Assurance Expert in Pharmacovigilance
il y a 1 jour
Quality Assurance Expert in Pharmacovigilance (French Speaker) – VAF 166FrancePermanent contractMAIN ACTIVITIES FOR THE JOBSupport implementation of PV process in PV operational TeamsEnsure that SOP are up to date and regularly reviewed for improvement, following a risk based approach and performance improvement objectivesEnsure that SOP are user friendly and based on visual and graphics (Business process modeling methodology)Support continuous improvement to meet compliance goal and company objectivesManage non conformance and ensure implementation on time of CAPA plansBe the client point of contact for Quality topics when dedicated to a projectHave oversight on PV NC and CAPA plans, ensure consistency of data, provide reports, support Quality KPI trends analysis and ensure set up of remediation plan when neededTrain the PV Team to Quality process and use of eQMSSupport client audits, from team preparation, document preparation, meeting hosting and facilitating, preparation of audit response reportAct as lead auditor for internal / vendor auditExperience Details:8 + years’ experience within a Quality role in Pharmaceutical industry + previous role or knowledge in PV domainKey Skills Required:Management of client specific procedures, NC and CAPA for clientTrainer of OPS staff on Quality process (e.g. NC/CAPA)Writing of procedure, process mapping, gap analysisSupport of GVP auditsAbility to lead working group with clients, take minutes on flight, propose solutionClient facing to defend PLG process and find compromisesRequired Technical Skills:PV trainingQuality assurance specific trainingExperience in using QMS tools (such as ENNOV, Trackwise, Mastercontrol, Veeva etc)knowledge of methodologies such as ISO 9001 2015 standard, Six Sigma, Lean or CMMGraphical process modeling methods and tools (Visio)Skill in MS Office tools, Excel, SharePoint, Content Management toolsStrong Soft Skills:Partnership mindsetCommitment to deadlinesExcellent written and oral communication skillsCommunication with clientRequired Education:Bachelor’s or higher graduate degree in a science related field, or equivalent experienceRequired Languages:French + English (Native/Full Proficiency) #J-18808-Ljbffr
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Pharmacovigilance Activity Manager 381
il y a 1 jour
France Groupe ProductLife Temps pleinPLG is looking for a dedicated Pharmacovigilance Activity Manager to join our hub to oversee and work closely with our PV team to ensure compliance with regulatory standards and accurate safety data.ResponsibilitiesKey trainer for junior team members to increase quality and expand knowledge of PV case processingReview and identify areas of improvementProvide...
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