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)