Global Pv Systems Lead

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

**Role & Function**

At Sobi, we are transforming life for people with rare diseases. As an international biopharmaceutical company, we provide access to innovative treatments in the areas of haematology, immunology, oncology and specialty care. Sobi is a biopharmaceutical company with in-house capabilities that stretch from late-stage R&D, biologics manufacturing and supply, to patient access and distribution. The PV Systems Lead is responsible for the pharmacovigilance systems and databases utilized Sobi Pharmacovigilance.

You will take the lead in driving our Sobi PV digital strategy - to deliver efficiency, quality and compliance with worldwide PV regulations. This role brings together responsibilities for the operations of our present Sobi PV systems (a cloud based, vendor hosted, safety database), leading our internal Sobi PV Systems team and our ESP team in order to maintain the Sobi PV systems configuration, access, processes et al, and to be taking the lead on our future PV system strategy and planning.

The PV Systems Lead reports into the Head of PV Systems and Operations. As part of our PV Systems and Operations management team you will be working collaboratively with the Head of PV Systems and Operations, PV Case Management Lead and PV Partnership & Operations Lead to ensure that the ICSR activities are conducted to the highest quality standards in compliance with GVP, GCP and regulatory requirements. We are looking for a motivated and collaborative professional who will contribute to shaping our team, develop our systems and processes and drive effective collaborations across Sobi and with our partner.

**Key Responsibilities**
- Lead the PV Systems team including, and the people and competency development of assigned staff
- Owns the strategy for the management of the GPV systems and IT projects (including introduction of new systems, upgrades and migrations) including cost and resources. Leads the coordinated delivery across the internal and external stakeholders.
- Act as the Sobi Business System Responsible for the Sobi global safety database and other key GPV IT systems including accountability for system host/vendor management, system operations, system maintenance, change control, user administration, periodic reviews, CAPA management and system development
- Act as delegate for QPPV for GPV system oversight including providing the QPPV with information from the database GPO for Sobi processes applicable to the GPV systems
- Setting the standards for Sobi PV system performance, testing, validation, documentation and subsequent performance oversight (includes oversight of technical and operational External Service Providers)
- Oversees the PV System Vendor Manager in their role working with PV IT systems in order to ensure clear alignment of requirements and delivery standards, clear communication of system performance status and appropriate maintenance of service delivery standards
- Leads the forward-looking digital strategy for GPV as we explore opportunities for GPV business process improvements e.g., system optimization and innovation, new technologies, benchmarking and best practices
- Single point of contact with Sobi IS/IT for projects within GPV from planning to implementation
- Explore opportunities to integrate with digital solution in other part of the Sobi business, such as QA, Clinical, Regulatory, IS/IT
- Responsible for inspection readiness for Sobi GPV Safety Systems
- Lead for audits and inspections related to Safety Systems.

**Qualifications**
- Bachelor’s/Master’s degree (or equivalent) in Pharmaceutical or Biochemical Sciences, Computer Science, Engineering Science or other related degree
- Pharma industry experience and experience from working with GxP systems and computer compliance
- At least 5 years of experience in management of relevant Information Systems for handling of GCP clinical and/or GVP safety data
- GxP systems experience including system selection, system implementation, system operations and external systems vendor management
- Experience in leading and developing teams. Evidence of effective management and supervisions of teams
- Strong organizational, planning, prioritizing and problem-solving skills

**Personal attributes**
- Ability to work effectively to deliver ambitious goals
- Team leadership and effectively team development and management.
- Work collaboratively in internal and external cross-functional settings and as part of matrix teams. Aligns on performance standards and then ensure those standards are delivered
- Ability to work proactively, independently, and collaboratively to solve problems and delive