Valneva

Develops, manufactures, and markets infectious-disease vaccines

Pharmacien Responsible

Regulatory & Quality (Life Sciences)Posted on Nov 5

Full-timeLyon, France

About the Job

Requirements

Be qualified as a pharmacist and registered with the French Order of Pharmacists, Section B, as required for appointment as Pharmacien Responsable.
Meet the professional experience requirements of Article R.5124-16 of the French Public Health Code, including extensive pharmaceutical Exploitant experience and interactions with regulatory authorities.
Have at least 10 years of relevant pharmaceutical-industry experience across pharmaceutical operations, quality management, regulatory compliance and pharmaceutical governance.
Have experience with Good Distribution Practice distribution and cold-chain requirements, and understand EU Good Distribution Practice and relevant Benelux distribution arrangements.
Have deep knowledge of French pharmaceutical legislation, particularly Exploitant and Pharmacien Responsable responsibilities, Good Practice requirements, Good Distribution Practice, Good Pharmacovigilance Practice oversight, and relevant EU and French regulatory requirements.
Exercise sound judgment and independence in pharmaceutical decision-making, public-health risk assessment and timely escalation.
Have strong knowledge of Quality Management System governance, deviations and corrective and preventive actions, change control, complaints, recalls, audits, inspections, suppliers and product shortages.
Be able to supervise outsourced local pharmacovigilance and medical-information interfaces while distinguishing Pharmacien Responsable oversight from operational Responsible Pharmacovigilance Person responsibility.
Have proven management, cross-functional leadership, communication, prioritization and crisis-management skills.
Be fluent in French and fully proficient in English.
Demonstrate integrity, objectivity, confidentiality, attention to detail and the ability to maintain complete, traceable documentation.

Responsibilities

Define and oversee the local pharmaceutical quality strategy and ensure effective implementation and continuous improvement of the Quality Management System in accordance with French regulations, Good Practice requirements and Group policies.
Ensure pharmaceutical governance, quality oversight, inspection readiness and compliance across local and outsourced activities.
Oversee deviations, corrective and preventive actions, change controls, quality complaints, supplier qualification, audits and quality risk management.
Ensure appropriate quality training, documentation, management reviews, and follow-up of inspections and regulatory commitments.
Ensure pharmaceutical compliance across the French distribution network, including third-party logistics providers, warehousing, transportation and cold-chain management.
Oversee product quality, batch traceability, recalls, withdrawals, temperature excursions and distribution-related quality incidents.
Ensure continuity of supply to the French market, including management of product shortages, safety stocks, and applicable shortage-prevention and management plans.
Coordinate with Group functions and external partners to manage and escalate supply and distribution risks.
Oversee local pharmacovigilance compliance within the French Exploitant perimeter, ensuring appropriate governance of outsourced pharmacovigilance activities.
Coordinate effectively with the external Responsible Pharmacovigilance Person/local pharmacovigilance provider, European Union Qualified Person for Pharmacovigilance, Global Pharmacovigilance, marketing authorization holders and relevant local stakeholders.
Monitor pharmacovigilance compliance and performance, escalate significant safety issues, and ensure implementation of required safety measures and regulatory obligations.
Oversee pharmaceutical and medical-information processes, ensuring appropriate handling and escalation of product-quality complaints and pharmacovigilance cases.
Ensure promotional activities and materials comply with applicable French regulations, including oversight of healthcare-professional interactions and promotional-team training.
Oversee local regulatory implementation, including marketing-authorization changes, product information, packaging, artwork and mandatory French requirements.
Monitor pharmaceutical regulatory developments and ensure implementation of relevant changes.
Lead the French Pharmaceutical Affairs function by setting priorities, responsibilities and objectives, and supervising deputy or delegated pharmacists and relevant external providers.
Work with General Management, Global Quality, Regulatory Affairs, Medical Affairs, Supply Chain and other Group functions to ensure effective pharmaceutical governance.
Represent the company in pharmaceutical matters with French competent authorities and relevant external stakeholders.
Exercise the statutory responsibilities, decision-making authority and approval duties of the Pharmacien Responsable in accordance with applicable French regulations.

Pharmacien Responsible

Valneva · Lyon, France (Hybrid) · Full-time · Posted 2026-11-05

Salary: EUR 100,000–120,000

Workplace: hybrid

Department: 18231

Description

Key Responsibilities – Pharmacien Responsable (France)

1. Pharmaceutical Quality Management & Compliance

Define and oversee the local pharmaceutical quality strategy and ensure the effective implementation and continuous improvement of the Quality Management System (QMS), in line with French regulations, GxP requirements and Group policies.
Ensure pharmaceutical governance, quality oversight, inspection readiness and compliance across local and outsourced activities.
Oversee deviations, CAPAs, change controls, quality complaints, supplier qualification, audits and quality risk management.
Ensure appropriate quality training, documentation, management reviews and follow-up of inspections and regulatory commitments.

2. Distribution, Product Quality & Supply Continuity

Ensure pharmaceutical compliance across the French distribution network, including 3PLs, warehousing, transportation and cold-chain management.
Oversee product quality, batch traceability, recalls, withdrawals, temperature excursions and distribution-related quality incidents.
Ensure continuity of supply to the French market, including the management of product shortages, safety stocks and applicable shortage prevention and management plans (MITM/PGP).
Coordinate with Group functions and external partners to manage and escalate supply and distribution risks.

3. Pharmacovigilance Oversight

Oversee local pharmacovigilance compliance within the French Exploitant perimeter, ensuring appropriate governance of outsourced PV activities.
Ensure effective coordination with the external RPV/LPPV provider, EU-QPPV, Global PV, MAHs and relevant local stakeholders.
Monitor PV compliance, performance and escalation of significant safety issues, ensuring implementation of required safety measures and regulatory obligations.

4. Medical Information, Promotion & Regulatory Compliance

Oversee pharmaceutical and medical information processes, ensuring appropriate handling and escalation of product quality complaints and pharmacovigilance cases.
Ensure compliance of promotional activities and materials with applicable French regulations, including oversight of healthcare professional interactions and promotional team training.
Oversee local regulatory implementation, including marketing authorization changes, product information, packaging, artwork and mandatory French requirements.
Monitor pharmaceutical regulatory developments and ensure implementation of relevant changes.

5. Pharmaceutical Governance & Leadership

Lead the French Pharmaceutical Affairs function, setting priorities, responsibilities and objectives, and supervising deputy/delegated pharmacists and relevant external providers.
Work closely with General Management, Global Quality, Regulatory Affairs, Medical Affairs, Supply Chain and other Group functions to ensure effective pharmaceutical governance.
Represent the company in pharmaceutical matters with French competent authorities and relevant external stakeholders.
Exercise the statutory responsibilities, decision-making authority and approvals of the Pharmacien Responsable in accordance with applicable French regulations.

Requirements

-Pharmacist qualified and registered with the French Order of Pharmacists (Section B) as required for the PR appointment.

-Professional experience meeting Article R.5124-16 of the French Public Health Code; extensive experience in a pharmaceutical Exploitant and interactions with regulatory authorities.

-Minimum 10 years of relevant experience in the pharmaceutical industry, including pharmaceutical operations, quality management, regulatory compliance and pharmaceutical governance.

-Experience with GDP distribution and cold-chain requirements; sound understanding of EU GDP and relevant Benelux distribution arrangements.

-Deep knowledge of French pharmaceutical legislation (especially Exploitant/PR responsibilities), GxP, GDP, GVP oversight and relevant EU/French regulatory requirements.

-Sound judgement and independence in pharmaceutical decision-making, public-health risk assessment and timely escalation.

-Strong knowledge of QMS governance, deviations/CAPA, change control, complaints, recalls, audits, inspections, suppliers and product shortages.

-Ability to supervise outsourced local pharmacovigilance and medical information interfaces without conflating PR oversight with operational RPV responsibility.

-Proven management, cross-functional leadership, communication, prioritization and crisis management skills.

-Fluent in French, fully proficient in English is a must-have

-Integrity, objectivity, confidentiality, attention to detail and ability to maintain complete traceable documentation.

Benefits

Private Health Insurance (Mutuelle)
Paid Time Off (CP/RTT)
Work From Home (1 day/week)
Training & Development
Performance Bonus (on top of base salary)

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About the Company

Valneva

Develops, manufactures, and markets infectious-disease vaccines

Valneva develops, manufactures, and sells specialty vaccines to prevent infectious diseases with high unmet medical needs, including Lyme disease, COVID-19, and chikungunya, plus travel health vaccines. Its vaccines work by training the immune system to recognize and fight specific pathogens, supporting public health through preventive immunization. It differentiates itself through a focused, niche vaccine portfolio, active involvement in travel health and clinician education, and partnerships with governments and international organizations, along with ESG commitments. Its goal is to improve access to safe vaccines and protect public health by addressing critical health needs worldwide.

Company size: 501-1,000
Company stage: IPO
Headquarters: Saint-Herblain, France
Founded: 1999

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