Costa Rica Job Openings
Viatris
Pharmacovigilance Vendor Oversight Specialist (Asia/MEA)
FULL TIME
September 11, 2024
Upjohn Export B.V. sucursal Costa Rica
Every day, we rise to the challenge to make a difference and here’s how the Pharmacovigilance Vendor Oversight Specialist (Asia/MEA) role will make an impact:
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.
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 Pharmacovigilance Vendor Oversight Specialist (Asia/MEA) role will make an impact:
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
The primary responsibility of this role will be act as the primary contact, and to ensure strong oversight of, any vendors performing PV activities on behalf of Viatris in the APAC, Middle East and Africa region.
This person will have proven and demonstrable experience overseeing the day-to-day activities of the vendors, resolving queries and questions pragmatically and in a timely manner, for the escalation of issues where necessary, and for monitoring performance through clear KPI’s and metrics.
Key responsibilities for this role include:
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Support PSRM by ensuring full PV vendor compliance to Viatris procedures and relevant legislation. Act as the primary vendor contact and serve as point of liaison for topics including but not limited to the following:
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Local Individual Case Safety Reports (ICSR)
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Local Literature Search
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Regulatory intelligence
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Local Product Safety Master File (L-PSMF)
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Risk Management Plan and implementation of additional Risk Minimization Measure
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Local Periodic Safety Update Report (PSUR)/Aggregate Report Management
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Product Labelling Changes
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Regulatory Authority Communication
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Pharmacovigilance Training
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Pharmacovigilance Business Continuity Plan (BCP)
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Signal Management and Benefit Risk Assessment
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Urgent Safety Alert support
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Pharmacovigilance Audit and Inspection
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Compliance monitoring and metrics
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Pharmacovigilance data archiving
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Corrective and Preventive Action (CAPA)
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Collaboration with local distributors to fulfil local PV requirements, as required.
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Oversee and verify monthly invoices and support for the payment process.
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Development, establishment and tracking of metrics and KPI’s to monitor performance.
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Other duties as assigned by Manager/ Regional Management.
The minimum qualifications for this role are:
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Life Science degree (or equivalent).
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Minimum of 5 years pharmacovigilance experience. Some of this experience may come having worked for a vendor/ CRO, but experience within the Pharmaceutical Industry is preferred.
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Knowledge of local and regional pharmacovigilance requirements, legislation and best practices, ideally across the APAC, Middle East and Africa region.
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Proven experience working closely with vendors, overseeing and managing daily activities.
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Fluent in 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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