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.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

Work from the office in Issy-les-Moulineaux, France. is required a minimum of 2 days/week. The individual can work from home the other days of the week.

The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities:

Safety and PV System Management

• Perform the quality check of the PV cases and ensure that the English translation has been properly performed.
• Keep up to date a local tracker of the individual safety reports.
• Be the subject matter expert at local level on the case management activities.
• Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.
• Establish and maintain local indicators on the compliance of the safety reports submission.
• Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable.
• Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
• Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Perform other agreed tasks assigned by manager
• Perform document management and archiving as required

Procedural Document

• Ensure current knowledge of all relevant company procedures and training.
• Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements.

Audit & Inspection readiness

Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable

PV contract management

Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information

Business Continuity

Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Education and Experience:

Education: health care science professional or equivalent training

• Significant training in data management with strong IT skills.
• 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…).
• Fluent in English. French as a mother tongue.
• Excellent communication skills and ability to work with cross-functional teams.
• Rigor is a key skill for this mission.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV

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