[france] Manager for Clinical and Pharmacovigilance

**Company Description** Santen **is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
**Job Description** Job’s mission**

As a Quality Assurance Manager, your primary responsibility will be to assist with Clinical quality and Pharmacovigilance/Safety vigilance—quality processes oversight in Santen SAS, EMA, and APAC regions. Your work will directly contribute to the success of our clinical development projects, products, and programs, helping us meet our aggressive and important goals. The position reports to the Head of Global Clinical and PV/Safety Vigilance Quality.

**Key Responsibilities** **& Accountabilities**

Following the General Company Policy and Principles on Quality, the primary purpose of the QA Manager role is:
**Clinical Quality/Good Clinical Practice (GCP) area**:

- To assist with oversight of Quality and compliance with clinical development projects, products, and programs. Promote Quality culture throughout Santen. Help establish a culture that supports open dialogue and continuous company-wide improvement. Creating a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to Quality for a particular study or development program, going beyond sole reliance on tools and checklists, is encouraged.
- To work in collaboration with the Clinical Department, Pharmacovigilance/Safety Vigilance EMEA, APAC, and other functional areas as needed on the implementation of the Santen Quality Management System to achieve a high level of current Quality and compliance to regulated activities, company standards, and expectations of regulatory authorities.
- To provide guidance to Clinical Operations, Data Management, clinical supply, and Drug Safety to develop their self-inspection activities (TMF review, investigator site visits, etc.) as appropriate.
- To support Clinical Operations with quality-related issues and provide guidance when necessary
- To ensure patient safety and rights in compliance with applicable regulations by providing continuous support to clinical teams during the project lifecycle.
- Assist with conducting study-specific eTMF audit for inspection readiness
- To implement and maintain the Quality Management System in the GCP area in accordance with the local and global requirements
- To develop, maintain, and follow up quality metrics for GCP in collaboration with Clinical
- Operations, Data Management, and Drug Safety to achieve high-quality data
- To develop and implement global clinical trials GCP audit plan using a risk-based approach To develop and implement GCP internal audit plan.
- To conduct internal GCP audits as scheduled or to outsource them when time conflict occurs.
- To perform QA assessment of Contract Research Organizations and external service providers. Review service provider selection and management process documentation for completeness and advise management.
- To conduct and/or supervise qualified auditors in scheduling, conducting, reporting, and following up audits as planned.
- To prepare and to deliver to stakeholder’s periodic reports based on metrics and quality trends To perform vendor and investigational site's audit oversight (plan, manage and document audits performed for Santen
- To ensure that deviations and incidents are properly identified, managed and timely escalated when required.
- Based on audits and document review to provide guidance in determining root causes and ensure that appropriate corrective and preventive actions are efficiently implemented in all major and critical audit findings
- To participate in all health authority inspections at Santen sites as part of the global QA team or as a single point of contact based on company regulations
- To conduct GCP training for R&D employees according to company policy or to support such training when outsourcing as needed.
- To ensure readiness for GCP and GPvP inspections. Prepare investigator sites for announced regulatory inspections.

Region: Primary EMA, and Secondary: APAC

**Good Pharmacovigilance Practice (GPvP) area**:

- To implement and maintain the Quality Management System in the GVP area in accordance with the local and global requirements.
- To develop quality metrics for GPvP in collaboration with Drug Safety.
- In connection with the above to prepare periodic reports based on metrics and quality trends (electronic AE reporting, signal management, electronic PSUR submissions, and PSMF update of certain parts).
- To ensure that the deficiencies identified are properly managed (to implement risk management and criticality evaluation, grading system)
- Based on audits and document reviews to provide guidance in determining root causes