Pharmacovigilance Officer (Temporary)
3 days ago
Barcelona
Laboratorios Théa is part of the independent Théa Group, a leading European pharmaceutical company specialized in ophthalmology. We are committed to improving patients' quality of life through innovation, scientific excellence, and the highest standards of quality, safety, and regulatory compliance. We are looking for a Pharmacovigilance Officer to join our Spanish affiliate. This position is initially offered as a 6-month temporary contract, with the possibility of becoming a permanent role depending on business needs and individual performance. This is an exciting opportunity to contribute directly to patient safety and product risk management within a dynamic international pharmaceutical environment. Key Responsibilities Reporting to the Deputy Pharmacovigilance & Quality Assurance role, and working closely with the Technical Director, local cross-functional teams, and Théa Group Pharmacovigilance colleagues, the successful candidate will: • Manage the collection, processing, assessment, documentation, and reporting of adverse events and other safety information related to Théa medicinal products., • Perform case intake, follow-up, and quality review of Individual Case Safety Reports (ICSRs), ensuring completeness, accuracy, and compliance with regulatory requirements., • Contact healthcare professionals, patients, pharmacies, distributors, and other reporters to obtain missing information and ensure appropriate follow-up of safety cases., • Ensure all pharmacovigilance activities are performed within applicable regulatory timelines and company procedures., • Monitor and achieve pharmacovigilance KPIs related to case processing, follow-up activities, literature screening, and reporting compliance., • Conduct routine literature surveillance and scientific literature reviews to identify potential adverse reactions, safety signals, and emerging safety information., • Support signal detection, safety evaluation, benefit-risk assessment, and risk management activities as required., • Collaborate with Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, and Customer Service teams to ensure proper identification and escalation of safety information., • Support the preparation, maintenance, and continuous improvement of pharmacovigilance procedures, local agreements, compliance documentation, and training records., • Assist in pharmacovigilance audits, inspections, and implementation of CAPA plans., • Maintain accurate pharmacovigilance documentation, records, and metrics in accordance with internal procedures and regulatory requirements., • Participate in local and international meetings to ensure alignment with Théa Group Pharmacovigilance objectives and processes. Our Pharmacovigilance Environment As a pharmaceutical company holding marketing authorizations, our pharmacovigilance activities are primarily focused on the post-marketing phase (Phase IV), involving the continuous monitoring of the safety profile of marketed medicinal products throughout their lifecycle. The role contributes directly to the identification, assessment, understanding, and prevention of adverse reactions and other medicine-related risks. Candidate Profile Required Qualifications • University degree in Pharmacy, Biology, Biotechnology, or another Life Sciences discipline., • Previous experience in Pharmacovigilance within the pharmaceutical, biotechnology, or healthcare industry., • Knowledge of European Pharmacovigilance legislation and Good Pharmacovigilance Practices (GVP)., • Experience handling adverse event case management and follow-up activities., • Strong organizational skills and attention to detail., • Ability to manage multiple priorities while working within strict regulatory deadlines., • Excellent written and verbal communication skills., • Fluency in Catalan, Spanish and English, written and spoken. Preferred Qualifications • Experience within a pharmaceutical affiliate environment., • Experience with literature surveillance and safety database activities., • Experience interacting with health authorities, pharmacovigilance partners, or service providers., • Experience participating in audits and inspections., • Knowledge of ophthalmology products or specialty pharmaceutical products. What We Offer • Opportunity to join a leading international ophthalmology-focused pharmaceutical company., • Direct contribution to patient safety and product risk management., • Broad exposure to local and global pharmacovigilance activities within an international organization., • Cross-functional collaboration with Pharmacovigilance, Quality Assurance, Regulatory Affairs, Medical Affairs, and Commercial teams., • Dynamic and collaborative working environment., • Hybrid working model., • Initial 6-month temporary contract, with the possibility of conversion into a permanent position. If you are passionate about patient safety and would like to further develop your pharmacovigilance career within a dynamic and international pharmaceutical environment, we would be delighted to hear from you. Join Théa Spain and help us ensure the safe and effective use of medicines for patients worldwide. Laboratorios Théa is an Equal Opportunity Employer. We are committed to fostering an inclusive and diverse workplace and welcome applications from all qualified candidates regardless of gender, gender identity, sexual orientation, age, disability, ethnic origin, nationality, religion, or any other legally protected characteristic.
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