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Responsible Pharmacist
Pharmanovia
Description du poste
About the role
We are seeking an experienced Responsible Pharmacist to lead all pharmaceutical operations for Pharmanovia’s French entity. The role carries statutory responsibility under the French Public Health Code and works closely with senior leadership and cross‑functional teams to ensure compliance, quality and uninterrupted supply of medicines in France.
Key responsibilities
- Act as the legally appointed Responsible Pharmacist for Pharmanovia France, ensuring full compliance with the French Public Health Code and all relevant legislation.
- Oversee regulatory compliance, quality assurance, pharmacovigilance, distribution, import/export, storage, transportation and batch recall activities.
- Maintain continuous supply of medicines by proactively managing supply risks, shortages and emergency requirements.
- Lead the Pharmaceutical Quality Management System, driving continuous improvement, compliance monitoring and governance.
- Ensure adherence to Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) and keep the site inspection‑ready at all times.
- Review, approve and sign regulatory submissions, including Marketing Authorisation Applications (MAAs) and other documents requiring Responsible Pharmacist sign‑off.
- Provide strategic regulatory leadership throughout the product lifecycle, from new product introductions to post‑approval variations.
Required profile
- Qualified pharmacist with experience acting as a Responsible Pharmacist under French law.
- Deep knowledge of the French Public Health Code and European pharmaceutical regulations.
- Proven ability to lead cross‑functional teams and manage complex pharmaceutical operations.
Required skills
- Good Distribution Practice (GDP)
- Good Manufacturing Practice (GMP)
- Pharmacovigilance
- Regulatory submissions and Marketing Authorisation Applications (MAAs)
- Pharmaceutical quality management system (PQS)
- Supply risk and shortage management
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