Director, Safety Surveillance & Risk Management

Viatris Inc.; Hatfield; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A leading healthcare company is seeking a Director of Safety Surveillance & Risk Management to oversee pharmacovigilance activities and ensure compliance with regulatory standards. The role involves coordinating safety reports, managing risk plans, and providing medical guidance. Candidates should have a medical degree and experience in drug safety. This position offers a competitive salary and benefits, including a hybrid work model and career development opportunities.

Benefits

Competitive compensation package

Annual discretionary bonus

Career progression opportunities

Hybrid work model

Health & Wellness programmes

100% paid medical insurance

Life cover

Employer-matched pension scheme

Paid volunteer days

Qualifications

• Previous experience in pharmacovigilance as a drug safety physician is preferred.
• Ability to manage own workload and interact well in a team environment.

Responsibilities

• Coordinate Periodic Safety Update Reports and Risk Management Plans.
• Provide medical safety expertise and training to personnel.
• Assist in global pharmacovigilance activities.

Skills

Time Management

Teamwork

Education

M.B.B.S/MD/BDS/PhD

Job description

Director, Safety Surveillance & Risk Management page is loaded

Director, Safety Surveillance & Risk Management

Solicitar locations Hatfield, England, United Kingdom time type Tiempo completo posted on Publicado ayer job requisition id R5658650 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:

Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;

Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;

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

Assist in the global pharmacovigilance activities within global PSRM for Viatris in accordance with Company, international standards and regulatory requirements, as assigned.

Every day, we rise to the challenge to make a difference and here’s how the Director, Safety Surveillance & Risk Management role will make an impact:

Role responsibilities:

• Responsible for co-ordinating Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.

• Responsible for co-ordinating Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department) within timely manner.

• Responsible for Signal Management related activity (including signal detection by company methodology, medical review of signalling reports, communication and escalation to CPSC)

• Responsible for assisting in:

  • CCDS development, review and updating

  • Maintenance of RSI

• Health Authority Responses

  • Assists in preparing or prepares responses to Regulatory Authority questions related to safety issues and conducts medical review

• Provides safety input into Medical Risk Assessments (MRAs), drives the process from SST and develops and follows-up the quality issues having safety implications.

• Reviews and provides medical/safety inputs in the Product Information and labelling issues.

• Liaises with internal and external stakeholders in performance of the above mentioned tasks.

• Assists in any other Pharmacovigilance department projects, as necessary

• Provides medical safety expertise and training to other personnel, as necessary

• Keeps current with professional and pharmacovigilance regulations and knowledge

• Provides medical guidance to PV Officers/ Senior PV Officers in medical aspects of drug safety and any other Viatris personnel

• Writes & updates of Standard Operating Procedures (SOP)

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:

• M.B.B.S/MD/BDS/ PhD or equivalent degree

• Previous experience working within pharmacovigilance as a drug safety physician is preferential.

• Excellent time management skills and ability to work to tight timelines.

• Ability to manage own workload and interact well in a team environment.

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.

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 inclusive of annual discretionary bonus

• Focus on career progression with growth and development opportunities

• Hybrid work model

• 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

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

En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.