Global PV Case Management Lead

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 Global PV Case Management Lead leads our Sobi Case Management team, reporting into the Head of Global PV Systems and Operations.

You and your team are the drivers for optimising the single safety case delivery at Sobi. You will take the lead in the development of our engagements with our case management external service providers. Working with those ESPs on systems, processes and people development to deliver compliance and safety cases to best understand the safety of the Sobi portfolio.

As part of our PV Systems and Operations management team you will be working collaboratively with the Head of PV Systems and Operations, 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 have big plans for our Sobi PV system. To expand the systems we will keep exploring how to best utilise internal and external staff, and to keep looking at the processes we use. We are looking for a motivated and collaborative leader who will contribute to shaping our team, develop our systems and processes, and to drive effective collaborations across Sobi and with our partner. Sobi is a fast-changing company, and this role is key to ensuring the Sobi PV system is proactively evolving to support our company as it expands and grows.

Key Responsibilities

• Be the driver for the implementation of a new case processing outsourcing model
• Lead and develop the Sobi Global Case Management team including people management, training, performance management, professional development and ensuring clear roles & responsibilities.
• Accountable for external PV vendor development and oversight, including quality, performance and compliance of cases, support budget review and strategies of tasks outsourced to ICSR processing vendor.
• Management of roles and responsibilities between Sobi team and case processing vendor
• Supports and develops in collaboration with the Vendor Manager the implementation of the Vendor Management processes and tools, supports development and maintenance of Quality Agreements (QAs) and different service levels agreements (as applicable).
• Actively contributes to the development of a robust governance model and ensures that activities and documentation are agreed with relevant stakeholders are reviewed and updated on a regular basis
• Develops strategic partnership Key Performance/Quality indicators (KPIs/KQIs) and assesses needs for process improvement
• Drive decision making on administrative and operational matters and ensures the Global Case management team effectively achieves its objectives.
• Drives communication and training to ensure case management team and outsourcing vendor adhere to the operating model and efficient execution.
• Serve as the Global Process Owner of the ICSR processes including case management, literature monitoring and reconciliation and reporting with configuration of distribution rules
• Accountable to ensure Sobi Case Management process is in line with current global regulatory requirements for Safety operational activities and support the interpretation and implementation of new or existing legal requirements together with case processing vendor.
• Drive safety database migration projects and give operational business input
• Lead for audits and inspections related to Global Case Management.
• Responsible for inspection readiness for Global Case Management

Requirements

• University level qualification in biosciences, healthcare or pharmacy
• At least 10 years of relevant work experience in Pharmacovigilance within the pharmaceutical industry
• At least 7 years involving case management including safety database configurations to meet PV business needs and regulatory reporting
• In-depth knowledge and experience of pharmacovigilance processes, practices, and regulations e.g., GCP and GVP.
• Experience of building effective outsourcing models for global case processing
• First-hand experience of working directly with and overseeing case processing external service providers, and demonstrated ability of managing and working with cross-functional teams in a complex, changing environment
• Knowledge of the Pharmaceutical Industry, especially clinical research, and global regulatory requirements
• Experience in managing and supervising internal (local and remote) and external teams
• Strong organizational, planning, prioritizing and problem-solving skills