\\n 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\\xe2\\x80\\x99s/Master\\xe2\\x80\\x99s 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 deliver solutions. Has the experience, expertise, determination, and courage to problem solve or escalate issues as appropriate

• Relationship builder both internally and externally, a strong collaborator within PV function and the wider organization

• Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive, and decisive.

In addition, you must demonstrate behaviors in line with Sobi\\\'s core values: Care, Ambition, Urgency, Ownership and Partnership.

Location

The position will be based in Flexible.

Reporting to

Head of Global PV System & Operations

Recruitment contact & how to apply

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we\\xe2\\x80\\x99re ready to take on the world\\xe2\\x80\\x99s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others\\xe2\\x80\\x99 lives because that\\xe2\\x80\\x99s exactly what we do here. If you\\xe2\\x80\\x99re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.

This has been our approach since day one, but we know we can\\xe2\\x80\\x99t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

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