Pharmacovigilance QA Manager
vor 2 Wochen
**We are looking for...**:
....a highly motivated **Pharmacovigilance QA Manager **for our **Development** department.
**Your tasks**:
- 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 and take responsibility for interaction with the Competent Authorities, and for the preparation, conduct and follow up of inspections performed at client's sites and partners as applicable. Represent PV QA at local and/or global inspections
- Responsible for escalation of significant PV compliance issues to the Global head of safety
- Provide in a timely manner the necessary QA output to the Global head of safety and EU QPPV to establish and maintain the PSMF Quality section and audit related PSMF annexes
- 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
- Perform QA effectiveness checks
- Ensure appropriate and timely management of non-conformances related to relevant GxP: deviations, change controls, internal and external CAPAs, Quality Events
- 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
- Drive accountability for Quality and Compliance to foster a compliance and quality driven culture
**Your profile**:
- 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
**About us**:
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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