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
Every day, we rise to the challenge to make a difference and here’s how the EEA QPPV & UK QPPV - (Based Anywhere in EEA) role will make an impact:
Fulfils legal EEA QPPV requirements, including EEA residency and continuous availability to the MAH.
Acts as 24/7 contact for EU competent authorities and EMA; supported by Deputy QPPV.
Oversees the PV system, ensuring implementation and compliance with quality standards.
Ensures the PSMF is maintained and kept up to date.
Establishes and maintains a system which ensures that information about all suspected adverse reactions, which are reported to the personnel of the company and to medical representatives, is collected and collated in order to be accessible at least at one point within the EU
Ensures compliance with legal and Good Pharmacovigilance Requirements (GVP) requirements, including document submissions.
Ensures accuracy and completeness of pharmacovigilance data submitted to to the EEA competent authorities and the EMA
Coordinates responses to regulatory authorities for additional PV-system information.
Monitors and acts on PV-system deficiencies and compliance issues.
Has awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or safe use of medicinal products for which the company is Marketing Authorization Holder within the EEA
Has oversight on the safety profiles and emerging safety issues in relation to medicinal products for which the company is Marketing Authorization Holder within the EEA. Contributes to the response to emerging safety issues
Participates in key committees, including PSOC (PV System Oversight Committee), CPSC (Corporate Product Sagfety Committee), and Governance Leadership Team.
Acts as UK QPPV for UK authorised products.
Participates in PASS (post-authorisation safety studies) reviews and PSRM/IT steering committees.
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:
MD or University Degree in Life Sciences or Pharmacy
Minimum 10 years’ experience within Pharmacovigilance
Broad and proficient understanding and experience in all areas of Pharmacovigilance
Experienced professional operating within the international arena, and working across functional areas
Proven strong leadership skills
Excellent negotiating skills, tact and diplomacy
Advanced knowledge of standard business procedures including quality management, communication with health authorities
EEA residency is required for this role
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.
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.