- Company Name
- Revolution Medicines
- Job Title
- Senior Director, Responsible Pharmacist (Pharmacien Responsable), France
- Job Description
-
**Job Title**
Senior Director, Responsible Pharmacist (Head Pharmacist)
**Role Summary**
Lead all pharmaceutical operations at a clinical‑stage oncology company in France, ensuring compliance with national and EU regulations. Oversee manufacturing, distribution, pharmacovigilance, batch monitoring, marketing authorisations, and quality systems, while staffing and directing pharmacists. Partner with cross‑functional teams and regulatory agencies.
**Expectations**
- Maintain full compliance with French Public Health Code, GMP, GDP, and Good Pharmacovigilance Practices.
- Provide timely pharmacovigilance reporting and liaise with ANSM, EMA, and other authorities.
- Manage and develop the team of pharmacists, including hiring, evaluation, and delegation.
- Support medical, marketing, compliance, and market‑access functions.
- Participate in senior management deliberations affecting pharmaceutical responsibilities.
**Key Responsibilities**
- Organise and supervise manufacturing, distribution, import/export, storage, and batch monitoring.
- Ensure proper transport conditions and safety of medicines.
- Accept and review marketing‑authorisation dossiers and related applications.
- Develop research study programmes and maintain quality systems.
- Authorise, delegate, and oversee pharmacists and deputy pharmacists.
- Notify ANSM of falsified products or new risk information.
- Implement quality management system based on GMP/GDP.
- Provide subject‑matter expertise on EMA, ANSM, EUDRAGMDP, and the Directive on falsified medicines.
- Communicate regulatory updates and obstacles to senior leadership.
**Required Skills**
- In‑depth knowledge of French and EU pharmaceutical regulations.
- Strong leadership and team‑management skills.
- Expertise in GMP/GDP, pharmacovigilance, and quality systems.
- Excellent communication and stakeholder‑management abilities.
- Ability to interpret and apply regulatory guidance to operational processes.
**Required Education & Certifications**
- Qualified pharmacist (Pharm.D or equivalent) licensed in France.
- Experience (≥10 years) in pharmaceutical operations, preferably in a biopharma or life‑sciences environment.
- Certification in pharmacovigilance or quality management (e.g., ISO 9001, GMP/GDP).
- Knowledge of ANSM and EMA regulatory processes.