Contribute to the development and implementation of the strategy of the Company in France in ensuring the development of the product portfolio in accordance with Code de la Santé Publique, allowing the availability of the product portfolio in France, guaranteeing the pharmaceutical quality of the marketed products in compliance with French regulations and laws, with international regulations and laws, with Company standard operating procedures and with Company group Policies.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Guarantee the pharmaceutical liability of the Company as an “Exploitant” (see definition of an Exploitant, art. R.5124-2, 3° of the French Health Public Code) and assume the role of “Pharmacien Responsable” (registered at ANSM and CNOP) (Chief Pharmaceutical Officer) such as described in article R.5124-36 of the French Public Health Code and in particular:
• Pharmaceutical monitoring
• Follow-ups, including complaints management, potential recalls, etc.
• Monitoring distribution
• Pharmacovigilance
• Medical information
• Promotion: advertising and sales force training
• Organize the Quality system within Company in accordance with French laws and regulations (updated Good distribution practices, Good pharmacovigilance practices, Good manufacturing practices) and with company requirements:
• Quality assurance (procedures, audits, pharmacovigilance, etc.)
• Medical REPs charter
• Additional activities:
• Activities in relation with the European teams
• Will assume Responsibility of Local Responsible for PV and be declared as such to ANSM
• Compliance (anti-gift law and transparency declaration)

Regulatory affairs:
• Follow up of the opening authorization application/status for the exploitant facility
• Filling and submission of the annual facility master file (once a year)
• Follow-up of the MA application and local commitments with the Health competent authority – the French Agency for the Safety of Medicines and Health Products (ANSM)
• Implementation of change control after regulatory approvals (marketing authorization, variations, risk management plan, etc.)
• Packaging and traceability management:
• Marketing monitoring (report to health authority on initial marketing date, prohibition or restriction decisions or
any information that can influence the benefit to risk assessment)
• Medinfo and promotion management
• Training material validation
• Free samples management
• Archiving management
• Regulatory survey
• Risk management approach (document management, complaints, audits, continuous improvement, premises,
suppliers, shortages, etc.) and business continuity plan
• Supervision of pharmaceutical contracts (headquarters and outsourced activities) and technical agreement
• Clinical studies follow-up with Medical if any (for studies with French investigators centers)

Drug safety management (with operational delegation to subsidiary or medical department):
• Implementation of pharmacovigilance process
• local Qualified Persons responsible for Pharmacovigilance and deputy, organization of 24/7 duty
• Interaction with European Qualified Person responsible for Pharmacovigilance (QPPV) and European PV department
• Procedures and data management
• Report to Competent authorities
• Collection, registration, assessment, report and follow-up of adverse events in line with Group SOPs
• Screening of scientific and medical literature for pharmacovigilance relevant information
• Signal detection
• Review and validation of Periodic Safety Update Report (PSUR)
• Reconciliation of shared PV data
• Review of key performance indicators (KPI)
• Report of off-label use to French authority
• Answer to Authorities survey requests
• Risk minimization plan implementation

Medical information management (with operational delegation to subsidiary or medical department):
• Implementation of medical information process (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

Quality assurance / supply chain:
• Conduction of regular audits of internal pharmaceutical activities (drug safety, medical information, promotion process, complaints, etc.) and pharmaceutical service providers
• Manage Regular audits and inspections from authorities (ANSM, etc.)
• Batch tracking/traceability
• Batch recall management with Marketing Authorization Holder, Health authority and distributor
• Shortage management Plan and stock-out alert
• Storage and distribution management with distributor
• Quality complaints: collection, reporting, inquiry and closure management
• Standard Operating Procedures (SOPs) and quality system
• Sales representatives charter certification
• Quality compliance implementation:
• Audits planning, execution and follow-up:
• KPI (definition, collection and analysis of KPI for major pharmaceutical activities)

Compliance management:
• Implementation of French anti gift law and Transparency reporting
• Implementation of guidelines on interactions with healthcare professionals, Providers, Payers and Patient Organizations
• Legal review of agreements with healthcare professionals, hospitals, organizations, etc.
• Personal data protection management
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Doctor in pharmacy, registrable at CNOP
• Specialization in regulatory affairs, and quality
• 7 years of experience in an equivalent function
• Solution orientated with excellent problem-solving skills
• Perfect communication skills
• Discretion & ability to handle sensitive information