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 Manager is a new role within our Sobi Pharmacovigilance Systems and Operations Team. You will be part of 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 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 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.

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**
- 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 3 years’ experience post-graduation in the pharmaceutical industry within the area of Pharmacovigilance.
- Thorough knowledge of regulatory Pharmacovigilance requirements during Clinical Trials as well as Post Marketing including Good Pharmacovigilance Practices (GVP) and ICH Guidelines
- Preferred experience in single safety case processing, vendor management, PV partner management and pharmacovigilance agreements

**Personal Attributes**
- Work collaboratively in various cross-functional settings and as part of matrix teams
- Ability to work proactively, independently, and collaboratively with colleagues
- Relationship builder both internally and externally, a strong collaborator within PV function, the wider organization and with partner companies
- Has the experience, expertise, determination, and courage to problem solve or escalate issues as appropriate
- 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.

**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.