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
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 and Risk Management role will make an impact:
Developing and implementing the overall drug safety strategy for the product, aligning it with business objectives and regulatory requirements.Establishing and maintaining ongoing monitoring of drug safety, including signal detection, evaluation, and risk assessment.Ensuring adherence to global pharmacovigilance regulations, guidelines, and reporting requirements.Developing and implementing risk management plans, including strategies for mitigating potential safety risks.Collaborating with other departments (e.g., clinical development, regulatory affairs, medical affairs) on safety-related matters.Preparing and presenting safety-related information to internal stakeholders (e.g., senior management, safety committees) and external stakeholders (e.g., regulatory authorities, data safety monitoring boards).Performing critical medical review of aggregate reports, providing medical input in safety matters impacting labelling and any safety request received from competent health authorities.Provide expertise and support in pharmacovigilance projects, including SOP updates and quality systems.Deliver training and guidance to team members and other departments on drug safety procedures, regulations, and best practices.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:
Requires a medical degree (MD)Extensive experience in pharmacovigilance and drug safety for innovator products, with a proven track record of leading teams and managing complex safety issues.Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, EMA, FDA).Excellent communication, leadership, and interpersonal skills.Experience in risk management, signal detection, and safety surveillanceAt 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
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.