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Head of Regional Psrm

5 months ago

Hatfield, United Kingdom Viatris Full time

1478 Generics [U.K.] Ltd.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Head of Regional PRSM (R-PRSM), is overall responsible to define the overall Regional Pharmacovigilance & Operational strategy for Viatris across its world-wide territories (>150 countries) in order to meet all the local & global Pharmacovigilance regulatory requirements, as well as Viatris global policies & procedures.

The R-PRSM oversees the management of the Regional Managers and ensures the function is in compliance with company, international standards and regulatory requirements in all countries through their leadership team.

To ensure all PV procedures & PV quality documents are in line with Policies, SOPs, Work Instructions, forms and specifications and such documents are understood, regularly reviewed and reflect state-of-the-art as appropriate in each country/region via teams led through Regional Leads.

Every day, we rise to the challenge to make a difference and here’s how the Head of Regional PRSM role will make an impact:
- This position is responsible for ensuring a robust oversight and control of PV service providers through a rigorous assessment process and monitoring plan of PV services delivered- Responsible for resourcing and budgeting for all regional organization for world-wide countries in scope.- Maintain awareness of changes to regulatory guidance documents, requirements and state-of-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.- Participate in due diligence ensuring clear recommendations for progression to agreement.- To work with cross functional Leaders in other departments [Medical, Regulatory, Quality, Legal, BD, Commercial, etc.]- To meet company objectives and to represent the Global PSRM Department in delivering quality and timely input to meet the needs of the project/s.- Lead or contribute to the implementation of large-scale initiatives and/or organizational changes (functional optimization) that affect the department- Support and oversee performance of affiliates working with all functions to meet business goals- Provide support to concerned countries before, during and after audits/inspections, including CAPA development and review- Responsible for the training, development, objective setting and performance reviews across the global team- Promote the Viatris Patient Safety Strategy across the organization contributing to the global Viatris Strategy

About Your Skills & Experience- Minimum a Life-sciences Bachelor’s / Master’s degree (or equivalent), Pharmacy or Medical degree- Extensive experience within the pharmaceutical industry and pharmacovigilance at Regional or Global Management level.- Broad and proficient understanding and experience in all areas of Pharmacovigilance, including Good Pharmacovigilance Practices and a good understanding of national pharmacovigilance regulations across worldwide countries- Demonstrable and proven strong managerial & leadership skills with the ability to inspire and motivate a team- Lead team through change management skills, including advocating, anticipating and orchestrating change. Able to foster a team culture that enables staff to achieve results in a changing environment- Ability to work in a matrix, remote organization, and international cross-functional teams- Strong focus on producing key deliverables (quality/time/costs)- Ability to plan and prioritise multi-task / multi-project workload and deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines- Experienced professional operating within the international arena, and working across functional areas

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusi