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Role and 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 Partnership & Operations Lead is a new role within our Sobi Pharmacovigilance Systems and Operations Team. You will lead a small team who facilitate the effective interface and ongoing linkages between the Sobi PV Systems & Operations teams and our internal and external business partners. You and your team will work with Sobi stakeholders to ensure that our products, marketing authorisations and clinical trials are appropriately presented and maintained within the Sobi PV systems and are understood by our case processing external service providers. You and your team will be the single point of contact for the PV interactions with our co-development, co-promotion and distributor partners, building effective ongoing partnerships and supporting the creation and overseeing the operationalisation of pharmacovigilance agreements.
The PV Partnership & Operations 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, Global PV Systems Lead and Global Case Management 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 Partnership & Operations team:
- Lead the development of the Sobi PV Partnership & Operations team, the Sobi PV Partnership & Operations Manager role, and the people and competency development of assigned staff
- Ensure PV Partnership & Operational Managers have required support (expertise, processes and systems) to facilitate their effective interactions with development partners, co-marketing partners and distributors for their respective assigned portfolios
- Support PV Partnership & Operational Managers in their assigned activities
- GPO for partner case processing quality documents
- Take the lead for PV Systems and Operations to coordinate the PV Systems and Case Management elements of Pharmacovigilance Agreement development and implementation
- Maintain oversight of the PV Partnership activities
- Responsible for inspection readiness for PV Partnership & Operations and lead for audits and inspections related to PV Partnership & Operations activities
Perform PV Partnership & Operations Manager for portion of Sobi portfolio
- Take the PV functional lead for new and existing Sobi partner collaborations with regards to PV alliance leadership, PV operational activities and PV process alignment
- Single point of contact between PV Systems & Operations and Safety Science on product specific questions
- For Clinical Studies,
- Coordinates the Safety Management Plan across External Service Provider and Sobi functions to ensure appropriate R&Rs for case management and reporting
- Coordinate with the PV Systems team to ensure the PV systems are appropriately configured for the product, ongoing clinical trials and marketing authorisations
- Work with Clin Ops/ GRA/ CRO stakeholders to ensure transfer of safety data from the EDC system and delivery to HAs, IRBs and investigators
- Coordinate with the Clinical Data Management to support SAE reconciliation
- For Marketed Products,
- Coordinates the preparation and maintenance of the case processing Product Safety Information guide
- Review Market Research and Patient Support Program materials for impact on case processing
- Partners and Distributors
- Lead operational interactions and meetings with Partners and distributors
- Coordinate the PV Systems and Operations input to PVA/SDEAs
- Work with partners to ensure obligations within the PVA/ SDEAs are met
- Works with partners to ensure appropriate quality of exchanged single cases
- Oversight of the single case reconciliation with the partner
- Quality
- Work with product level Safety Science Leads to ensure appropriate quality of single case data to support aggregate reporting and signal management activities
- Pro-actively identify quality and compliance issues and support non-conformance investigations
- SME for audits and inspections related to PV Partnership & Operational Management.
- Database Migrations
- Coordinate with the PV Case Management and PV Systems teams for database migrations
- Support the PV Case Management team with user testing and documentation
Qualifications
- University level qualification in biosciences, healthcare or pharmacy
- At least 5 years of relevant work experience in Pharmacovigilance within the pharmaceutical industry
- In-depth knowledge and experience of pharmacovigilance processes, practices, and regulations e.g., GCP and GVP. Knowledge of the Pharmaceutical Industry, especially clinical research, and global regulatory requirements
- Experience in leading and developing teams. Evidence of effective management and supervisions of teams
- Strong organisational, 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
- Ability to work proactively, independently, and collaboratively to aolve 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 organisation
- Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive, and decisive.
In addition, you must demonstrate behaviours in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
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’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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’t 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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