Senior Pharmacovigilance Officer (maternity cover)

Viatris Inc.; Hatfield; On-site; GBP 35,000 - 55,000; Full time

Job summary

Una empresa innovadora busca un Oficial de Farmacovigilancia Senior para proporcionar apoyo global en ensayos clínicos. Este papel es crucial para garantizar la seguridad de los pacientes a través de la gestión de eventos adversos y la colaboración con equipos de investigación. La posición ofrece un entorno dinámico donde se valora la atención al detalle y la capacidad de trabajar bajo presión. Si tienes experiencia en farmacovigilancia y un deseo de hacer una diferencia en el cuidado de la salud, esta podría ser la oportunidad ideal para ti.

Benefits

Seguro médico 100% pagado

Programa de asistencia al empleado

Días de voluntariado pagados

Plan de pensiones con contribución del empleador

Qualifications

• Experiencia de 3-5 años en gestión de casos de ensayos clínicos.
• Conocimiento de los principios de farmacovigilancia en ensayos clínicos.

Responsibilities

• Recepción y revisión de eventos adversos de ensayos clínicos.
• Generación de consultas de seguimiento y presentación de casos clínicos.
• Comunicación periódica con CROs y equipos de desarrollo clínico.

Skills

Gestión de ensayos clínicos

Atención al detalle

Manejo del tiempo

Conocimiento de farmacovigilancia

Trabajo en equipo

Education

Grado en farmacia/ciencias de la salud

Título en ciencias de la vida

Tools

Base de datos ARGUS

Job description

Senior Pharmacovigilance Officer (maternity cover)

Senior Pharmacovigilance Officer (maternity cover)

Solicitar locations Hatfield, England, United Kingdom time type Tiempo completo posted on Publicado hoy job requisition id R5658390 Generics [U.K.] Ltd.

En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.

Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.

Lo hacemos a través de:

1. Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;
2. Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;
3. Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.

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

Senior Pharmacovigilance Officer role within Global Safety Surveillance and Risk Management & Clinical Safety involves providing global pharmacovigilance support to Viatris clinical trials globally, which includes Phase I, Phase II, Phase III and Phase IV trials across different therapeutics and hundreds of Bioequivalence, Pharmacokinetic Bioavailability studies worldwide across various therapeutic groups in accordance with Company, international standards and regulatory requirements, as assigned.

Every day, we rise to the challenge to make a difference and the Senior Pharmacovigilance (PV) Officer role will make an impact through the following responsibilities:

• Receipt, triage, and Data entry/Quality review for serious events and/or adverse events of special interest as per protocol originating from Viatris sponsored global clinical trials.
• Generating follow up queries and reporting/submission of clinical trial cases electronically including E2B submissions and via email. Also responsible for unblinding of cases for regulatory reporting purposes.
• Managing clinical safety mailbox for incoming SAE reports on daily basis.
• Periodic (Monthly/Quarterly/End of study) reconciliation of SAE’s between safety and clinical database for Viatris sponsored clinical trials by liaising with CROs and Business Partners.
• Assisting in the preparation and implementation of Global Clinical trial safety templates, including study specific safety plans.
• Maintaining Schedule of periodic line listings in liaison with concerned CROs and provision of line listing in a timely manner to CROs for submission to various Health Authorities / Ethics Committees as required.
• Periodic communication with CROs, Clinical Development team and internal Global Product Safety & Risk Management team about study progress and maintaining study tracker and individual study folders.
• Highlighting issues identified (e.g. with reporting, procedures, compliance monitoring) to the Clinical Safety Manager and contributing to the development of measures to resolve them.
• Responsible for the preparation and maintenance of assigned Pharmacovigilance procedures in accordance with current regulations and company policies.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:

• Graduate or post-graduate in pharmacy/health sciences.
• Life science degree or Qualified Health Professional (e.g. pharmacy technician, pharmacist, nurse).
• Previous substantial work (3-5 years) experience in clinical trials case management is preferential.
• Sound understanding of the principles of Pharmacovigilance in Clinical trial set up.
• Attention to detail, excellent time management skills and must be able to work to tight timelines.
• Familiarity with use of Pharmacovigilance databases (ARGUS safety database is preferential).
• Ability to manage own workload with minimal input from and interact well in a team environment.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
• Competitive compensation package
• Focus on career progression with growth and development opportunities
• Emphasis on Health & Wellness programmes
• 100% paid medical insurance and Employee Assistance Programme
• Life cover
• Excellent employer-matched pension scheme with Viatris contributing up to 11%
• 2 paid volunteer days per year

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility