Global Pv Partnership

**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 i