PV Partnership & Operations Director

Job Description

The PV Partnership & Operations Director provides strategic leadership, accountability and effectiveness of the Sobi PV Partnership & Operations function, ensuring productive collaboration between Sobi PV Operations, internal stakeholders (including clinical development functions and clinical development teams), co-development, co-promotion and distributor partners, and external service providers (GPV and clinical development vendors).

Under the overall lead of the Head of Global PV Operations, the PV Partnership & Operations Director works together with the PV Vendor Management Director and the PV Licensing Director to ensure the overall delivery of the Sobi PV Operations function. The focus of the PV Partnerships and Operations being towards the “customers” of GPV and the ongoing maintenance and compliance of activities associated with these partners. The role is accountable for partner-related PV operations activities, including the operationalisation and ongoing compliance with pharmacovigilance agreements, ensuring PVA commitments are adhered to from both Sobi and partners sides, and oversight of case exchange and reconciliation activities. The role is generally more focused towards product level engagements – in terms of product level Partner engagements, and product and study level development and clinical trial activities. The role works closely with PV Licensing for the set up and implementation of PVAs, and with PV VM to direct the delivery of Sobi PV vendors.

Together with GPV Safety Science and appropriate Sobi RDMA functions, this role has a strategic leadership to drive best practices for clinical trial operations, clinical trial systems and clinical trial vendor management. This includes PV delivery that is both GVP and GCP inspection ready and compliant

The Director leads and develops the PV Partnership & Operations team. This global team of “product aligned” PV Partnership Managers are responsible for the product level deliverables. The team members are located in several countries.

Key Responsibilities:

Functional leadership and team management

• Lead the PV Partnership & Operations function, assigning and coordinating activities across the team, setting strategic direction, priorities, operating model, governance structures and performance expectations.
• Provide overall accountability for the function’s activities, deliverables, quality, compliance, risk management, performance monitoring and inspection readiness. Highlighting areas of concern to GPV Management
• Lead, develop and oversee the PV Partnership & Operations team, including resource management, recruitment, performance management, capability building, coaching, escalation support and succession planning.

Partnership governance and pharmacovigilance agreements

• Provide PV functional leadership for new and existing Sobi partner collaborations, including alliance leadership, operational activities, PV process alignment, governance meetings and escalation processes.
• Accountable for that partner and distributor obligations under PVAs and SDEAs are clearly defined, implemented and fulfilled.
• Accountable for case exchange elements in Pharmacovigilance Agreements and Safety Data Exchange Agreements (inc oversight and reconciliation). Identification of delivery gaps and development and delivery of appropriate corrective actions.
• Maintain oversight of case exchange quality, timeliness, completeness and reconciliation activities, ensuring discrepancies are investigated and resolved appropriately.
• Work with PV VM team, and through the VM Team if applicable with the Sobi PV eESPs, to understand concerns on performance and quality, and to develop and implement appropriate corrective actions.

Clinical studies, marketed products and safety data management

• Work with the ODT Tech lead and OSIRIS Config team to ensure the appropriate configuration for products, clinical trials and marketing authorisations.

• Lead the development of, and overall accountability, for “study level” Safety Management Plans across Sobi functions and external service providers, ensuring clear roles and responsibilities and delivery and quality expectations for case management and safety reporting within clinical studies.
• Accountable for study training of case processing vendor
• Oversee collaboration with Clinical Operations, Global Regulatory Affairs, Contract Research Organisations, Clinical Data Management and other stakeholders to ensure appropriate transfer, reconciliation and reporting of safety data.
• Accountable for preparation, approval and maintenance of “product level” case-processing Product Safety Information guides and appropriate assessment of Market Research and Patient Support Program materials for PV impact.

Quality, compliance, audits and inspections

• Work closely with GPV Excellence, Sobi QA, PV VM, other Sobi function and external vendors to we ensure quality and compliance standards and defined and maintained for PV activities with “partners”.

• Ensure quality and compliance of PV Partnership & Operations activities, including proactive identification and management of operational, quality and compliance risks.
• Work with Safety Science Leads to ensure individual case safety data are of appropriate quality to support aggregate reporting and signal management activities and ensure feedback, with appropriate corrective measures, to case processing vendor
• Act as the senior subject matter expert for audits and inspections relating to PV Partnership & Operations activities
• Oversee non-conformance investigations, corrective and preventive actions, issue escalation, inspection readiness, and preparation, coordination and follow-up of relevant audits and regulatory inspections.

PV systems, databases and cross-functional collaboration

• Responsible for ensuring that new and/or changed PV partnerships, study or product activities that impact the Sobi PV system and Sobi PV Vendor operations are appropriately flagged and addressed by the responsible teams (inc Sobi PV VM, Osiris Configuration team). Together with responsible functions, ensuring systems are set up and functioning appropriately to meet Sobi GPV PV commitments.
• Leadership of the PV Partnership team contribution to company acquisitions, product integrations and other business development activities with impact on the Sobi PV system. Including contribution to the future PV operating model, clear alignment of roles and responsibilities between Sobi PV and a partner, design and delivery of a PV data migration and integration of products and activities into the Sobi PV system.  PV system configuration and operational readiness across products,
• Oversight of the respective PV Partnership Manager in the design, set up, operations and close out of the PV system to support Sobi sponsored clinical studies and ISSs
• Accountable for the Drug Safety inbox and to ensure oversight and continued coverage by the team.
• Serve as the senior functional interface between PV Operations, Safety Science and relevant Sobi business functions on product-specific and process-related matters (e.g. case processing questions).

Qualifications

Education/Learning Experience/Work Experience

Required:

• University level qualification in biosciences, healthcare or pharmacy.
• At least 10 years of relevant pharmacovigilance experience within the pharmaceutical industry, including strong experience in case processing, clinical study safety data management, partner/vendor oversight and applicable GVP, GCP and global regulatory requirements.
• Experience leading and developing teams, including effective people management, supervision, capability building and prioritisation of work in a complex operational environment.
• Strong organisational, planning, prioritisation and problem-solving skills.

Desired:

• Working knowledge of IQVIA Vigilance Platform.
• Previous international / global people management experience.

Skills/Knowledge/Languages

• Thorough knowledge of GVP and GCP.
• Fluent English, written and spoken.

Personal Attributes

• Ability to work effectively to deliver ambitious goals.
• Effective team leadership, team development and management. Able to prepare, empower and support assigned team to cover the broad range of deliverables this team is responsible for.
• Ability to work collaboratively in internal and external cross-functional settings and matrix teams.
• Proactive, independent and collaborative problem-solver with the judgement, determination and courage to resolve or escalate issues as appropriate. Able to drive collaborative assessment and solution development and effective implementation to complex and cross functional and cross company problems encounters
• Strong relationship builder and collaborator within PV and across the wider organisation.
• Clear communicator, able to distill down large amounts of information to root cause and propose appropriate actions.
• Sound and balanced judgement; able to assess and manage risks; self-confident, proactive and decisive.

Additional Information

Compensation and Total Rewards at Sobi

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,900 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.