Senior Director, Responsible Pharmacist (Pharmacien Responsable), France

The Opportunity:

General Purpose 

The Senior Director, Head Pharmacist/Responsible Pharmacist guarantees the pharmaceutical responsibility of the laboratory as “exploitant” (see definition of the “exploitant”, Article R.5124-2, 3 ° of the French Public Health Code) and assumes the role of "Responsible Pharmacist" as described in Article R.5124-36 of the Public Health Code. Responsibilities include:

• Organize and supervise all pharmaceutical operations of the company or organization, including manufacturing, advertising, information, pharmacovigilance, batch monitoring and withdrawal, distribution, import and export of the drugs, products, objects or articles concerned, as well as the corresponding storage operations.

• Ensure that transport conditions guarantee the proper preservation, integrity and safety of these medicines, products, objects or articles.

• Acknowledge the files related to marketing authorization applications submitted by Corporate or organization and any other application related to the activities they organize and supervise.

• Participate in the development of research and study programs.

• Imperson authority over delegate and deputy pharmacists; approve their hiring and be consulted on their dismissal, except in the case of an army pharmacist-chemist.

• Appoint interim delegate pharmacists.

• Inform the other directors of the company or organization of any obstacle or limitation to the exercise of these powers.

• Implement all necessary means to comply with the obligations set out in articles R. 5124-48 and R. 5124-48-1;

• In the case of medicinal products intended to be marketed in the territory, he(she) ensures that the safety measures referred to in article R. 5121-138-1 have been affixed to the packaging in accordance with the conditions set out in articles R. 5121-138-1 to R. 5121-138-4;

• Notify the Agence nationale de sécurité du médicament et des produits de santé (ANSM : French National Agency for the Safety of Medicines and Health Products) of any launching on the national market of a medicinal product which is considered to be falsified within the provisions of article L. 5111-3, and for which they are responsible for the manufacture, exploitation and distribution.

They organize 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.

They also support the transversal activities carried out by the marketing, medical, compliance and market access departments.

The Senior Director, Head Pharmacist/Responsible Pharmacist, France takes part in the deliberations of the management, administrative, executive or supervisory bodies, or those of any other body with an executive function, of the company or organization, when these deliberations concern or may affect the performance of the tasks falling under his/her responsibility as described above.

The RP is responsible for ensuring compliance with professional ethics and all regulations issued in the interests of public health. He/she must also ensure that the responsibilities of pharmacists and staff under his/her authority are clearly defined.

In accordance with articles L. 5121-14-3, R. 5121-152 and L. 5121-164 of the French Public Health Code, the RP ensures that pharmacovigilance cases are reviewed and processed within the appropriate timeframes.

In accordance with article L5121-9-2 of the French Public Health Code, the RP immediately informs the French National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product for human use is marketed, and of any other new information likely to influence the evaluation of the benefits and risks of the medicinal product for human use or the product concerned.

In addition, the Responsible Pharmacist also has knowledge of :

• the role of professional bodies and organizations that regulate those who supply medical products to the public.

• the ANSM's role in handling controlled drugs.

• the role of the European Medicines Agency (EMA) and the use of EUDRAGMDP.

• the Directive on Falsified Medicines.

• the principles and guidelines of good manufacturing practice, and how GMP/GDP principles maintain product quality throughout the distribution chain.

Responsibilities

In the performance of the duties, the Employee is responsible for the following tasks in French territory:

Regulatory Affairs:

• Submission and obtaining the opening authorization application for the “Exploitant” pharmaceutical establishment.

• Filling and 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 in the management of early access programs.

• Monitoring of drug marketing (declaration to the health authority of the date of initial marketing, reporting of prohibition or restriction decisions or any information likely to influence the benefit/risk assessment).

• Validation of the Advertising and Medical Information process.

• Participation in pharmaceutical document archiving management.

• Implementation of the Regulatory Intelligence process.

• Supervision of pharmaceutical contracts (head office and outsourced activities).

Quality Assurance/Supply Chain:

• Regular audits of internal pharmaceutical activities (distribution, medical information, promotion processes, claims, pharmacovigilance processes, etc.).

• Implementation of a risk management approach (document management, claims, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan.

• Implementation of change control management process following regulatory approvals (marketing authorization, variations, risk management plan, etc.).

• Participation in audits and inspections by authorities (ANSM, etc.).

• Follow-up of batch release for distribution in France and tracking/traceability.

• Management of batch recalls with the marketing authorization holder, the health authority and distribution stakeholders.

• Management of shortages with the health authority.

• Storage and distribution management.

• Management of quality complaints.

• Implementation of procedures (SOP).

• Implementation of compliance with the French Charter of Promotional Information and its Guidance.

• Implementing quality compliance:

• Planning, execution and follow-up of audits.

• Implementation of KPIs (definition, collection and analysis of KPIs for key pharmaceutical activities).

Pharmacovigilance and drug safety management:

• Implementation of the local pharmacovigilance process.

• Nomination of local Qualified Persons responsible for Pharmacovigilance.

• Interaction with European Qualified Person responsible for Pharmacovigilance (QPPV); Global Patient Safety Department (GPS)and PV database.

• Procedures and data management.

• Report to Competent authorities.

• Collection, registration, assessment, report and follow-up of adverse events.

• Screening of local scientific and medical literature for pharmacovigilance relevant information.

• Local Signal detection.

• Review and validation of Periodic Safety Update Report (PSUR).

• Reconciliation of shared PV data.

• Implementation of key performance indicators (KPI).

• Monitoring of product good use and off-label use, and declaration to competent authorities if applicable.

Medical information management:

• Implementation of medical information process in 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.

Advertising and promotional information:

Promotional and non-promotional material review and approval.

Review and submission to Health authority of promotional material.

Approval and dissemination of the positive list.

Logistical management of material with traceability (withdrawal, archiving, etc.).

Personnel training:

• Implementation of a local training process for pharmaceutical and compliance processes.

• Review and validation of training material for commercial and medical teams.

• Validation of integration and ongoing staff training plans, and monitoring of training plans.

• Ensuring that all staff are trained in Good Practices, their own tasks, product identification, risks of drug falsification and specific training for products requiring more rigorous handling.

• Competency assessment and empowerment of key personnel.

Participation to Compliance management:

• Participation to implementation of French law about anti-bribery, transparency and compliance of interaction with HCPs and HCOs.

• Participation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.

Management of the Pharmaceutical Affairs Department in France

• Team leadership, development and management;

• Recruitment, training and development of team members;

• Follow-up of team objectives.

The above list of tasks is not exhaustive.

Required Skills, Experience and Education:

• Doctor in pharmacy and able to be registered as Responsible Pharmacist.

• Specialization in regulatory affairs and quality.

• Minimum 15 years of proven experience in leadership roles within the biopharmaceutical industry in the field of oncology.

• Fluency in both verbal and written French and English.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• High capacity of social competence for teamwork, coaching and situational leadership.

• Proven track record shaping and executing country strategy and influencing policy at a senior industry level.

• In-depth knowledge of the French pharmaceutical market and regulatory environment.

• Ability to create and nurture a strong culture of collaboration and authenticity to extend and replicate the RevMed culture.

• Proven success in building effective relationships with internal stakeholders, regional authorities, and vendors.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.

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