Pharmacovigilance Compliance Manager

Company : Basilea Pharmaceutica Ltd, Allschwil

Job Type : Full Time

Allschwil

Job Description - Pharmacovigilance Compliance Manager

....a highly motivated Pharmacovigilance Compliance Manager for our Development department.

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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Pharmacovigilance Compliance Manager

Job Description - Pharmacovigilance Compliance Manager

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