Beschreibung

In this strategic role, you will enhance compliance in pharmacovigilance by leading audit programs, collaborating with stakeholders, and ensuring adherence to global regulations. Your expertise will drive policy decisions and foster a culture of quality across the organization.

Anforderungen

• •Experience in Commercial GDP QA/Supply Chain QA
• •Strong background in Pharmacovigilance/Drug Safety and master's degree in relevant scientific discipline
• •Expert knowledge of international Pharmacovigilance regulations
• •In-depth knowledge of pharmaceutical industry practices
• •Experience in training employees on GVP requirements
• •At least 10 years of QA/industry/health authority experience
• •Prior experience in coordination of Pharmacovigilance inspections
• •Reliability, conscientiousness, and goal orientation
• •Excellent problem-solving and risk management skills
• •Ability to work independently and in a team
• •Excellent communication and interpersonal skills
• •Ability to establish collaborative partnerships and apply diplomatic skills
• •Fluency in English; knowledge of German and French advantageous
• •Experience in GDP, warehousing, and distribution of commercial products
• •Proficiency in Microsoft Office applications

Aufgaben

• •Lead and manage PV compliance audit programs
• •Ensure standardized PV approach across affiliate sites
• •Establish and maintain relationships with internal stakeholders
• •Provide expert-level PV knowledge and guidance
• •Lead key project initiatives across the organization
• •Offer strategic advice to stakeholders for policy decisions
• •Act as local PV QA Manager for affiliate sites
• •Support affiliates in implementing local PV systems
• •Maintain and improve a global PV QA audit program
• •Perform PV QA audits of vendors and affiliates
• •Track, record, and report audit results consistently
• •Identify and document corrective/preventive actions
• •Cooperate with EU QPPV and national Affiliate Safety Managers
• •Prepare for and follow up on inspections at Idorsia sites
• •Escalate significant PV compliance issues to senior management
• •Provide QA output to establish and maintain PSMF Quality section
• •Ensure inspection readiness of vendors conducting PV activities
• •Review archiving procedures at affiliate sites
• •Evaluate CAPA and deviation management procedures
• •Manage non-conformances related to GxP
• •Collaborate with HQ QA on documentation and training records
• •Plan periodic information exchanges on PV system topics
• •Stay updated on global pharmacovigilance regulations
• •Inform management about changes in country-specific PV laws
• •Review key global and local Quality System documents
• •Drive accountability for Quality and Compliance

Tools & Technologien