Pharmacist and Pharmaceutical Affairs Manager, France & BeLux

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Purpose: The Delegate Pharmacist (PRI) manages by delegation the pharmaceutical activities of the laboratory as “exploitant” (see definition of the “exploitant”, Articles R.5124-36 ° of the French Public Health Code).He (she) contributes to the quality system within the laboratory in accordance with French laws and regulations (Good distribution practices, Good pharmacovigilance practices, Good manufacturing practices) and laboratory requirements.He (she) also supports the Pharmaceutical affairs team in its transversal activities carried out by the marketing, medical, compliance, sales, and compliance department.Essential Functions of the jobIn the performance of his/her duties, the employee is notably responsible for contributing to the following tasks under the responsibility of the Responsible Pharmacist, or for carrying them out directly by delegation:Quality Assurance/Supply Chain (France and BeLux): Participation to regular audits of internal pharmaceutical activities (distribution, medical information, promotion processes, claims, pharmacovigilance processes, etc.). Contributing to the risk management approach (document management, claims, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan. Follow up of change control management process following regulatory approvals (marketing authorization, variations, risk management plan, etc.). Participation to audits and inspections by authorities (ANSM, etc.). Participation to batch release for distribution in France and tracking/traceability Participation to batch recalls follow up with the marketing authorization holder, the health authority and distribution stakeholders,Participation to shortages follow up with the health authority Participation to storage follow-up and distributionManagement of quality complaints, deviations, CAPAs Implementation of procedures (SOP) Participation to the implementation of the French Charter of Promotional Information and its GuidanceFollow-up of quality compliance Follow-up of KPIs (definition, collection and analysis of KPIs for key pharmaceutical activities.Regulatory affairs (France and BeLux):Contribute to the maintenance of the opening authorization application for the “Exploitant” pharmaceutical establishment Submission of the annual facility master file (once a year) Relationships with the Health competent authority – the French Agency for the Safety of Medicines and Health Products (ANSM) Participation to the review and approval of packaging artworks and MARRsManagement pharmaceutical document archiving management Management of the Regulatory Intelligence process Pharmacovigilance management (France):Procedures and data management Follow up of key performance indicators (KPI) Participation to the good use and off-label committee, and declaration to competent authorities if applicable Medical information management (France and BeLux):Collaboration with the Medical information department (data management, standard responses, access to literature database) Collection, registration and response to medical information requests Reconciliation of shared medical information data Implementation of KPI Medical advertising and information (France and BeLux) Collaboration with the Commercial, Medical and Legal Departments for promotional and non-promotional material reviewSubmission to Health authority of promotional material Verification and approval of the positive list Management of material with traceability (withdrawal, archiving, logistics, etc.) Personnel training (France and BeLux)Contribution to trainings on pharmaceutical and compliance processesReview and approval of training material for commercial and medical teamsParticipation in the competency assessment and empowerment of key personnel.Participation to Compliance management (France and BeLux)Monitoring of local law about anti-bribery, transparency and compliance of interaction with HCPs and HCOsParticipation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.Verification of submissions of healthcare professionals/organizations’ care to local authorities, if neededTransparency disclosureThe above list of tasks is not exhaustive.Supervisory Responsibilities: Customers : Senior Director Head Pharmacist and Pharmaceutical affairs, Associate Director Pharmaceutical affairs, French and BeLux employees, Europe and Global employeesSuppliers : Consultants, subcontractorsEducation Required: Doctor in pharmacy and able to be registered as Delegate pharmacistSpecialization in regulatory affairs and qualityComputer Skills: Excellent proficiency with Office software systems (Excel, Word, PowerPoint) and OutlookOther Qualifications: 3 to 5 years of experienceTravel: Travel required on an ad hoc basicsGlobal CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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