PHARMACOVIGILANCE REGIONAL COORDINATOR - CROSS COUNTRY

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We are looking for a Pharmacovigilance Regional Coordinator based in São Paulo, Bogotá or Mexico City.
Essential Job Duties and Responsibilities • Patient Support Program (PSP) Pharmacovigilance interface o Support PSP PV interface, facilitating the implementation of processes improvement.
o Participate on the review evaluation of new PSPs, new PSP benefits and PSP strategies/campaigns implementation, besides PSP closure, supporting adequate PV requirements accomplishment.
o Liaise with the LSOs on PSP protocols/scripts updates.
o Implement periodic meetings with PSP stakeholders aiming ensure proper visibility to PV Case Management team regarding any PSP activity that may cause processing impact.
o Be responsible for insights and data generation, seeking to bring safety valuable data to PSP and the company business.
• Procedural and Regulatory Framework o Maintain proper oversight of internal procedures and regulatory requirements and ensure activities are conducted in accordance.
o Liaise with the LSOs to ensure that any changes in local regulations are properly communicated, assessed and implemented with the PSPs.
o Support LSOs on reconciliations when needed.
o Maintain updated training program to the PSPs.
o Support the maintenance of PSP PV controlled documents.
• Good Pharmacovigilance Practices and Inspection Readiness o Disseminate quality and compliance culture among the team and interface areas.
o Ensure activities are conducted in accordance with Good Pharmacovigilance Practices.
o Support PV Case Management Team in monitoring PV compliance metrics, implement corrective and preventive actions, when needed.
Promptly escalate any non-conformance identified.
o Support audits and inspections when required.
• Process improvement o Actively seek opportunities for process improvement and optimization; implement the changes as applicable.
• Regional and Global projects o Actively participate in regional and/or global project Pharmacovigilance related.
Qualifications • Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance • Deep knowledge of Pharmacovigilance requirements, including regulations and international guidelines.
• Fluent communication skills in English.
Spanish / Portuguese is desirable (not mandatory) depending on the applicable activities.
• Capability to manage multiple projects simultaneously.
• Excellent computer-based application skills • Leadership and negotiation skills, capacity of influencing internal and external stakeholders, assertive communication, analytical skill, problem solving.
Other Requirements • 3 – 5 years of experience