Audit assistant Jobs in Bern

PURPOSE OF THE FUNCTION

• Support the Head of Global Ops, Regions & QM and Regional PV Leads in ensuring that applicable pharmacovigilance (PV) deliverables, systems and processes are implemented, maintained and continuously improved in compliance with global, regional and local regulatory requirements.

• Serve as a regional pharmacovigilance resource for internal and external stakeholders, contributing to process harmonization, inspection readiness, safety data oversight and consistent application of argenx standards across regions.

• Reporting to: Head of Global Ops, Regions & QM

ROLES AND RESPONSIBILITIES

• Support the Head of Global Ops, Regions & QM and Regional PV Leads in the oversight, harmonization and maintenance of Regional PV activities, processes and deliverables.

• Contribute to the establishment and maintenance of the applicable pharmacovigilance system specific to the assigned country or region, ensuring alignment with global GPS processes and standards.

• Support in the monitoring and communicate applicable pharmacovigilance legislation, regulatory expectations and safety requirements that may impact Regional PV activities or the broader GPS function.

• Promote awareness of pharmacovigilance obligations and support compliance with local, regional and global requirements.

• Support the management and maintenance of company and user profiles in applicable regulatory authority databases and portals, as relevant to Regional PV activities.

• Collaborates with Regulatory, Medical, Quality, Legal, Commercial and other teams, as needed.

• Develop and maintain relationships with cross-functional teams as they relate to adverse event reporting, safety data collection and other PV activities.

• Support oversight of individual case safety report processes, including the management, quality and timely processing of cases into the Global Safety Database, in collaboration with relevant GPS teams and partners.

• Support the oversight and operational management of pharmacovigilance outsourcing vendors, including performance monitoring, issue escalation, quality follow-up and alignment with contractual and procedural requirements.

• Participate in GPS audit and inspection readiness, support and management together with GPS Quality Management and Quality teams.

• Maintain knowledge of the company product portfolio, disease areas, marketed products and products in development.

• Contribute to continuous improvement and innovation initiatives aimed at increasing Regional PV efficiency and process maturity.

• Perform other tasks as appropriate and requested.

SKILLS AND COMPETENCIES

• Good planning and organizational skills.

• Good oral and written communication skills, with the ability to clearly communicate complex issues to different audiences.

• Demonstrated ability to collaborate with and work effectively across multidisciplinary and global teams.

• Understanding of safety business processes, adverse event collection and pharmacovigilance systems.

• Problem-solving skills.

• Relevant computer skills, including proficiency with Microsoft Office Suite.

• Fluency in written and spoken English. Other languages are an asset.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare, life sciences or another relevant scientific field.

• Approximately 5 to 7 years of experience in the pharmaceutical or biotech industry, regulatory authorities or related environment, with solid experience in pharmacovigilance or drug safety.

• Working knowledge of pharmacovigilance regulatory requirements, GVP guidance documents and applicable GxP quality and compliance expectations.

• Experience in the preparation, review or maintenance of pharmacovigilance documents, procedures, work instructions or related controlled documents.

• High Experience with individual case safety report processes and the management of cases into a Global Safety Database.

• Experience in the oversight or management of pharmacovigilance outsourcing vendors, including operational performance, quality follow-up and issue management.

• Experience in audit and inspection readiness, inspection support or participation in pharmacovigilance inspections is preferred.

• Knowledge of regional pharmacovigilance operations, safety data collection and cross-functional PV processes is preferred.

To be considered for this role, candidates must be based in Belgium or Switzerland.

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Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.