Pharmacovigilance Specialist
hace 1 día
3866 Upjohn Export B.V. sucursal Costa Rica
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 of making a difference and that's how Pharmacovigilance Specialist will make an impact:
Supports the non-affiliated pharmacovigilance business in Latin America (i.e., Central America, South America, Caribbean), and other non-affiliated territories managed by the pharmacovigilance vendor, as applicable.
Support Product Safety and Risk Management (PSRM) department with regional pharmacovigilance business.
Acts as point of contact within PSRM for pharmacovigilance vendor and functions within Viatris (e.g., Regulatory Affairs, Marketing, Commercial, etc.).
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to calculate figures and amounts such as discounts and interest.
Role Responsibilities
Support the pharmacovigilance business by supporting PSRM and the pharmacovigilance vendor to ensure compliance to Viatris and vendor procedures, and legislation by acting as vendor contact and PSRM liaison for topics including but not limited to the following:
- Local Individual Case Safety Reports (ICSR).- Local Literature Search.- Local Product Safety Master File (L-PSMF).- Risk Management Plan and implementation of additional Risk Minimization Measure.- Local Periodic Safety Update Report (PSUR)/Aggregate Report Management.- Product Labeling Changes.- Regulatory Authority Communication.- Pharmacovigilance Training.- Pharmacovigilance Business Continuity Plan (BCP).- Signal Management and Benefit Risk Assessment.- Urgent Safety Alert support.- Pharmacovigilance Audit and Inspection.- Compliance monitoring and metrics.- Pharmacovigilance data archiving.- Corrective and Preventive Action (CAPA).- Collaboration with local distributors to fulfill local PV requirements, as required.- Other duties as assigned by Manager/ Regional Management.
Role Basic Qualifications- Minimum of a bachelor's degree (or equivalent), preferably with related health science or life science background, and 2-4 years of experience.
However, a combination of experience and/or education will be taken into consideration.- Knowledge of local and regional LATAM Pharmacovigilance legislation, requirements, and industry best practices.- Fluent in Spanish and English.
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.
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