Specialist RIM Data Maintenance

1100 Mylan Pharmaceuticals Inc.; Lisboa; Híbrido; EUR 35 000 - 52 000; Tempo integral

Resumo da oferta

Viatris in Lisbon is seeking a RIM Data Maintenance Specialist to provide user support for creating and maintaining records in the Regulatory Information Management system (Veeva Registrations). You will collaborate with Regulatory Affairs on data standards and oversee data cleansing and compliance checks to keep master data accurate.

The role is hybrid, requiring in-office presence three days per week with two days remote, and expects a technical background in life sciences or related fields

Qualificações

• BS/BA in technology field, life sciences field, or other relevant discipline.
• Pharmaceutical industry experience.
• Experience in Regulatory Affairs or Regulatory Operations preferred.
• Other pharmaceutical experience considered.

Responsabilidades

• Partner with Regulatory teams to create/revise records in the RIM system (Large global portfolio).
• Collaborate with Regulatory Affairs on field definitions, data entry standards, workflows, dashboards, searches.
• Perform data cleansing to ensure timely access to data for key systems.
• Support evaluation of data quality through system-generated checks.
• Assist with bulk updates and master data requests in the RIM system.
• Contribute to SOPs, user manuals and data standards.

Conhecimentos

Regulatory Affairs

Data maintenance

Data cleansing

Formação académica

BS/BA in technology or life sciences

Ferramentas

Veeva Registrations

Descrição da oferta de emprego

Mylan, Lda. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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

RIM Data Maintenance Specialist will provide user support for record creation and maintenance of records in the Regulatory Information Management (RIM) system (Veeva Registrations), address RIM related user questions and support with data cleansing and data compliance checks for information maintained in RIMS.

• Partner with the Regulatory teams on the creation/revision of records in the RIM system for a large, global portfolio of pharmaceutical products. This includes the creation of Application-level records, as well as Master Data level records.
• Collaborate with the Regulatory Affairs team to address queries related to the RIM system for field definitions, data entry standards, system workflows, dashboards, searches, etc.
• Participate in data cleansing operations to facilitate appropriate and timely access to data for key systems.
• Support the evaluation of data quality issues through the review/analysis of system generated consistency checks.
• Work with Regulatory colleagues to address items.
• Collaborate with the Regulatory Affairs team to help with bulk updates.
• Submit master data requests for dictionary updates to the RIM system.
• Propose improvements to the RIM system, processes, or procedures based on experience with use of the system.
• Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs), user manuals, and data standards.

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:

• BS/BA in technology field, life sciences field, or other relevant discipline
• Previous experience in pharmaceutical industry.
• Experience in Regulatory Affairs or Regulatory Operations is strongly preferred.
• Other pharmaceutical experience (e.g. Research & Development, Quality Assurance/Compliance) will be considered
• Hybrid role, requiring attendance in the office 3 days per week, with the remaining 2 days working from home.

Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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

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. Viatris is an Equal Opportunity Employer. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.