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A leading company in the pharmaceutical sector is seeking a skilled professional to oversee pharmacovigilance metrics and ensure compliance with local regulations. The role involves developing procedures, ensuring data quality, and maintaining training requirements. Candidates should have strong planning and organizational skills, along with advanced English and Spanish proficiency. Remote work options are available, making it an attractive opportunity for experienced professionals in the field.
Metrics and Oversight of the Pharmacovigilance System Supports the provision of metrics to ensure oversight of all aspects of the PV system's performance and functioning, in compliance with local regulations and internal company standards.
Quality Management System
Develops and maintains local / regional procedures aligned with corporate procedures and local requirements.
Supports the business continuity plan and testing.
Ensures local language review of medical or scientific literature.
Implements appropriate local quality control procedures to ensure data quality and reporting accuracy.
Completes AE reconciliation and ensures effectiveness sampling for AE identification, in line with global procedures.
Ensures PV requirements are met for activities involving safety information identification and handling, according to AbbVie procedures and local laws.
PV Training
Ensures compliance with PV training requirements, maintains the training matrix, and develops additional training materials as needed.
Monitors local and regional PV intelligence and assesses their impact.
Minimum 4 years' experience in pharmacovigilance or a related field.
Excellent planning and organizational skills, with high-quality activity completion.
Advanced English and Spanish skills, both written and spoken.
Remote work options are available.