Pharmacovigilance Compliance Manager
Vor 6 Tagen
We are seeking a highly motivated Pharmacovigilance Compliance Manager for our Development department.
Responsibilities- 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 a 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 teamwork.
- Experience in representing safety on cross-functional teams.
- Excellent communication skills, fluent in English, spoken and written; any other language is considered beneficial.
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing, and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
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