Junior Pharmacovigilance Officer/Pharmacovigilance Officer

at  Viatris

Mylan Healthcare Sp. z o.o
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 Junior Pharmacovigilance Officer/Pharmacovigilance Officer role will make an impact:

• Receive, assess and process incoming safety information from multiple sources, both internal and external, according to corporate policies and proce dures, and local regulation
• Perform follow-up for additional information
• Translate safety information, if applicable
• Evaluate local literature screening results
• Perform periodic reconciliation with internal and external partners
• Assist in review of local PV SOPs for alignment
• Keep relevant databases/trackers up to date
• Support the PV department in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented
• Ensure continual readiness for audits and inspections
• Support Corrective Action and Preventive Action (CAPA) plans
• Locally implement and track activities in accordance with Risk Management Plans (RMPs)
• Assist in CEP (Customer Engagement Program) activities
• Perform other PV-related duties as assigned
• Support the Affiliate Safety Representative (ASR) to organize, implement and maintain the Affiliate Pharmacovigilance (PV) System and implement local procedures, in addition to fulfil local regulatory and corporate requirements with respect to pharmacovigilance of Viatris products

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:

• Master’s degree or equivalent in natural sciences (preferable medical science or pharmacy)
• At least 1 year experience in PV/Regulatory (for PV Officer position)
• Fluency in Polish and English language required
• Detail oriented with a high degree of accuracy and ability to meet deadlines
• Strong organizational skills and excellent communication skills
• Knowledge and understanding of key legislation and guidelines applicable to pharmacovigilance desirable
• Excellent PC skills
• Ability to perform in stretched situations and tight deadlines

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.
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.

Every day, we rise to the challenge to make a difference and here’s how the Junior Pharmacovigilance Officer/Pharmacovigilance Officer role will make an impact:

• Receive, assess and process incoming safety information from multiple sources, both internal and external, according to corporate policies and proce dures, and local regulation
• Perform follow-up for additional information
• Translate safety information, if applicable
• Evaluate local literature screening results
• Perform periodic reconciliation with internal and external partners
• Assist in review of local PV SOPs for alignment
• Keep relevant databases/trackers up to date
• Support the PV department in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented
• Ensure continual readiness for audits and inspections
• Support Corrective Action and Preventive Action (CAPA) plans
• Locally implement and track activities in accordance with Risk Management Plans (RMPs)
• Assist in CEP (Customer Engagement Program) activities
• Perform other PV-related duties as assigned
• Support the Affiliate Safety Representative (ASR) to organize, implement and maintain the Affiliate Pharmacovigilance (PV) System and implement local procedures, in addition to fulfil local regulatory and corporate requirements with respect to pharmacovigilance of Viatris product

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Master’s degree or equivalent in natural sciences (preferable medical science or pharmacy)
• At least 1 year experience in PV/Regulatory (for PV Officer position)
• Fluency in Polish and English language required
• Detail oriented with a high degree of accuracy and ability to meet deadlines
• Strong organizational skills and excellent communication skills
• Knowledge and understanding of key legislation and guidelines applicable to pharmacovigilance desirable
• Excellent PC skills
• Ability to perform in stretched situations and tight deadline