Pharmacovigilance Compliance Manager
vor 3 Wochen
- Oversee all safety activities for compliance with internal SOP, plans and international regulations across all products in the company portfolio
- Ensure audit results are formally and consistently tracked, recorded, and reported
- Ensure corrective/preventive actions have been identified, documented and are effective
- Cooperate with the Global Head of Safety and EU QPPV to participate in internal and external audits, ensuring accuracy and audit readiness of all documentation
- Provide ongoing support during inspections, ensuring GPS teams and subject matter experts are prepared.
- Responsible for escalation of significant PV compliance issues to the Global head of safety
- Ensure inspection readiness of Basilea and Vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training
- Ensure procedures for archiving of records are in line with Basilea policies
- Monitor training compliance
- Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices
- Maintain oversight and review the content of key global and local Quality System documents
- Oversee development, maintenance, and continuous improvement of local PV processes in alignment with global GPS
- Collaborate with cross-functional teams to address compliance issues and improve processes
- Strong background in Pharmacovigilance/Drug Safety with a Master’s degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields)
- Prior experience in the coordination of Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g. FDA, EMA, MHRA, ANSM, BfArM, Health Canada, Swissmedic
- Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations & ICH guidelines) of medicinal products for human use
- Working knowledge of pharmacovigilance legislation
- Knowledge of product development processes & experience of cross-functional team work
- Experience in representing safety on cross functional teams
- Excellent communication skills, fluent in English, spoken and written, any other language is considered beneficial
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