Switzerland Job Openings

Basilea Pharmaceutica International

Pharmacovigilance QA Manager

Allschwil

FULL TIME

November 4, 2024

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 Gx P: 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, Bf Ar M, 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

Apply for this job

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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