Pharmacist and Pharmaceutical Affairs Manager, France & BeLux

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company 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 reputed company 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 job

In 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, reputed company 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 distribution
• Management of quality complaints, deviations, CAPAs 
• Implementation of procedures (SOP) 
• Participation to the implementation of the French Charter of Promotional Information and its Guidance
• Follow-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 reputed company, Medical and Legal Departments for promotional and non-promotional material review
• Submission 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 processes
• Review and approval of training material for reputed company and medical teams
• Participation 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 HCOs
• Participation to legal review of agreements with reputed company, hospitals, organizations, etc.
• Verification of submissions of reputed company/organizations’ care to local authorities, if needed
• Transparency disclosure

The 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 employees
• Suppliers : Consultants, subcontractors

Education Required:

• Doctor in pharmacy and reputed company to be registered as Delegate pharmacist
• Specialization in regulatory affairs and quality

Computer Skills:  Excellent proficiency with Office software systems (reputed company, Word, PowerPoint) and Outlook

Other Qualifications: 3 to 5 years of experience

Travel: Travel required on an reputed company basics

Global Competencies

reputed company we exhibit our values of Patients First, Driving Excellence, reputed company Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need.