Responsible Pharmacist
Pharmanovia
Job description
About the role
Pharmanovia is seeking an experienced Responsible Pharmacist to lead all pharmaceutical operations for its French legal entity. This senior leadership position carries statutory responsibility under the French Public Health Code and ensures compliance with French and European regulations.
Key responsibilities
- Act as the legally appointed Responsible Pharmacist for Pharmanovia France, ensuring full compliance with the French Public Health Code and all applicable legislation.
- Oversee pharmaceutical operations including regulatory compliance, quality assurance, pharmacovigilance, distribution, import/export, storage, transportation and batch recall activities.
- Maintain uninterrupted supply of medicines to the French market by managing supply risks, shortages and emergency supplies.
- Lead the pharmaceutical quality management system, conduct quality reviews and ensure inspection readiness.
- Review, approve and sign regulatory submissions such as Marketing Authorisation Applications.
- Provide strategic regulatory leadership throughout the product lifecycle and ensure product integrity across the supply chain.
- Oversee pharmacovigilance governance and delegate activities to the Local Qualified Person for Pharmacovigilance where appropriate.
- Manage investigations of quality defects, counterfeit or falsified medicines and report to the French Health Authority (ANSM).
- Maintain oversight of manufacturers, contract organisations, distributors and logistics providers to ensure regulatory compliance.
Required profile
- Qualified Pharmacist eligible to act as Pharmacien Responsable under French legislation, registered with the Ordre National des Pharmaciens.
- Significant experience as a Responsible or Deputy Responsible Pharmacist within the pharmaceutical industry in France.
- Extensive experience in pharmaceutical operations, regulatory compliance, GMP/GDP environments and pharmacovigilance.
- Proven track record interacting with ANSM and supporting inspections, audits and regulatory submissions.
Required skills
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Pharmacovigilance regulations and processes
- Quality Management Systems
- Marketing Authorisation procedures
- EU Falsified Medicines Directive compliance
What we offer
- Senior leadership position with significant strategic influence.
- Opportunity to shape pharmaceutical operations across France.
- Collaborative and entrepreneurial international culture.
- Career development within a rapidly expanding organisation.
- Competitive salary and comprehensive benefits package.
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Published 1 day ago
Expires 1 month from now
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