Pharmacovigilance Auditor

For our Global Pharmacovigilance & Regulatory Quality Assurance (PVRQA) / Global R&D Quality department in Bern we´re currently looking for a

Pharmacovigilance Auditor / Pharmacovigilance & Regulatory Quality Assurance Manager (f/m/d)

Position purpose

The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Manager is responsible for leading and coordinating the Global PVRQA activities in Europe (EEA & ECI) under the general direction of the PVRQA Regional Lead, to ensure that CSLB’s entire Pharmacovigilance (PV) System is in compliance with applicable pharmacovigilance regulations and requirements, GVP, ICH GCP guidelines, respective GxP guidelines, international standards, relevant regulatory requirements and company policies.

Under guidance of the PVRQA Regional Lead Europe, this position is responsible for the ongoing operational support of existing PV Quality processes and systems across multiple departments like Global Clinical Safety & Pharmacovigilance (GCSP), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA), Affiliates, Commercial Operations as well as other related interface departments in the region. The primary business processes include, but are not limited to: CAPA Management, Inspection Preparation and Management, Continuous Improvement, Compliance, 3rd Party Qualification, PV IT Systems and Procedural Quality Assurance. The position is also responsible for implementation of the Global PVRQA risk-based Audit Program in Europe under the guidance of the PVRQA Regional Lead.

**Main Responsibilities and Accountabilities**
- Support development and maintenance of the Global Pharmacovigilance & Regulatory Audit Program (PVRQA audits of applicable global systems, affiliates and 3rd party vendors) in Europe
- Execute the Pharmacovigilance Audit Program through performance of audits of internal pharmacovigilance (PV) processes/ procedures, local/ regional safety officers (LSOs/RSOs) in the affiliates, as well as 3rd party PV vendors/ PV distributors in order to ensure compliance with relevant guidelines, legal requirements, GVP and other relevant GxPs.
- Analyze audit observations, gaps and systematic issues to help to support continuous improvement within Global Clinical Safety and Pharmacovigilance (GCSP), Global Regulatory Affairs (GRA) as well as affiliates, 3rd party vendors and other interfacing functions. Evaluation of adequacy and completeness of corrective and preventative action plans (CAPAs) originated from audits, deviations and/or inspections. Includes identification of non-compliance trends and systematic risks as well as escalation of non-compliances/ trends.
- Provision of oversight of the qualification and ongoing management of PV service providers in Europe and performance of risk assessments
- Support / perform pre-inspections, mock-inspections for PV Health Authority Inspections. Support PVRQA/ Global R&D Quality Management with hosting and/or facilitating regulatory agency inspections.
- Provide GVP consultancy and other pharmacovigilance regulatory expertise to support the organization in maintaining required compliance
- Together with the PVRQA Regional Lead, ensure sufficient PVRQA presence in the region including profound and efficient interfacing with stakeholder functions (GCSP, GRA, affiliates, commercial operations) in relation to audit and inspection strategies as well as non-compliance trends
- Support maintenance and continuous improvement of PVRQA/ Global R&D Quality System (processes, tools, etc.).
- Collaborate with the Global R&D Systems and other Operational Excellence groups to drive continuous improvement initiatives identified through CAPA, internal compliance monitoring and industry best practices/trends.
**Qualifications and Experience**
- University degree (MSc/Diploma) in Scientific Discipline/ Life Sciences or other related disciplines.
- Minimum of 5 years of professional work experience in the pharmaceutical industry, minimum 4 years’ experience in a Quality Assurance or Compliance function with audit experience in Pharmacovigilance, preferably globally operating.
- In depth knowledge of industry regulations and pharmacovigilance processes with emphasis on local and international standards and regulations and associated GxP guidelines.
- Good knowledge of Pharmacovigilance / Good Clinical Practices regulations (GVP, CFR, GCP), quality systems (SOPs), CAPA programs, and audit procedures and reporting
- Strategic development and analytical skills
- Experience in managing processes with a continuous improvement approach
- Strong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skills
- Demonstrated ability to navigate and negotiate competing priorities in a challenging environment
- Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
- Ability to work and collaborate at all levels within an org