Pharmacovigilance Specialist

Descrizione del lavoro:

Leading French independent pharmaceutical Company, specialised in ethical medicinal products. 92% of Servier's sales are achieved internationally, with several subsidiary companies abroad. We are looking for V.I.E's, for our subsidiary in Panamá. Description of the mission: * Local PV system management: coordination with Global Safety and compliance with internal procedures and local regulations. * PV case management: receiving, assessing, and processing safety reports from all sources. * PSMF maintenance in accordance with local requirements. * Study and program oversight: ensuring adequate safety reporting processes for global/local clinical studies and compassionate use programs. * Signal detection: identifying potential safety signals and communicating them to Global Safety. * Aggregate report management: contributing to preparation, tracking, submission, and compliance with periodic safety reports. * Safety communication: responding to authority requests, managing safety-related communications, and supporting EEA-QPPV requirements. * Oversight of RMPs and additional risk minimization measures. * Local literature surveillance and processing of any identified ICSRs. * Labelling and regulatory commitments: supporting local safety label updates and implementation of commitments. * PV Quality System management: maintaining a compliant quality system, including training of staff and partners. * Pharmacovigilance agreements: drafting, negotiating, updating, and ensuring compliance with local PV agreements. * Key interface management: reconciliation of safety information with Medical Information, Quality, and other relevant departments. * Audit and inspection readiness: preparation, participation, and CAPA follow-up for audits and inspections. * Archiving PV documentation according to regulatory and data-protection rules. * Business continuity: ensuring PV activities continue outside business hours. * Support in SOP updates and creation. * Regulatory intelligence: monitoring local legislation, assessing impacts, and informing Global Safety

Requisiti del candidato:

Educational background: Studies in Pharmacy, Medicine, or Health Sciences (required) Specialization: N/A Field of study: Biology, Pharmacy, Medicine, or related Health Sciences studies. Languages: Fluent in Spanish and English (required) Experience required: Ideally 1 or 2 years of experience in pharmacovigilance, authority reports and database management. Computer skills: Microsoft Office Package Soft Skills: Interpersonal relations, empathy, capability to adapt to different situations, teamwork, organization and time management