Product Safety Specialist

Viatris • Torrington, WY

5d • $41,000 - $93,000 • Remote

About The Position

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. Every day, we rise to the challenge to make a difference and here’s how the Product Safety Specialist role will make an impact: Key responsibilities for this role include: Handle product quality complaint, adverse event and combination product follow-up reports, documenting each appropriately. Assist in performing timely submission of ICSR case reports to global regulatory authorities, business partners and licensing partners as applicable. Possess knowledge of entering case information and navigating PV Safety Database, including the advancing of cases within the workflow and understanding and conducting various medical coding applications. Perform timely submission of ICSR case reports to global regulatory authorities, business partners and licensing partners. Develop and maintain knowledge of Viatris products and their potential adverse events.

Requirements

• Minimum of a Bachelor's degree (or equivalent) and 4 years of experience.
• A degree in Nursing or Life sciences is preferred.
• However, a combination of experience and/or education will be taken into consideration.
• Must possess a strong clinical and scientific background.
• Must be familiar with electronic safety databases, coding dictionaries and query development.
• Must possess knowledge of Viatris products and their potential adverse effects.
• Must possess strong and effective communication, skills, and time management skills.
• Must possess good drug information research skills and be able to conduct on-line research.
• Must possess computer skills by using Microsoft Outlook.
• Ability to read and interpret complex business and/or technical documents.
• Ability to write comprehensive reports and detailed business correspondence.
• Ability to work with managers or directors and communicate ambiguous concepts.
• Ability to present to groups across the organization.
• Ability to add, subtract, multiply, and divide.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.
• Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
• Proficiency in speaking, comprehending, reading and writing English is required.

Nice To Haves

• A degree in Nursing or Life sciences is preferred.

Responsibilities

• Handle product quality complaint, adverse event and combination product follow-up reports, documenting each appropriately.
• Assist in performing timely submission of ICSR case reports to global regulatory authorities, business partners and licensing partners as applicable.
• Possess knowledge of entering case information and navigating PV Safety Database, including the advancing of cases within the workflow and understanding and conducting various medical coding applications.
• Perform timely submission of ICSR case reports to global regulatory authorities, business partners and licensing partners.
• Develop and maintain knowledge of Viatris products and their potential adverse events.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level