07 sep
|
Cv-Library
|
Cataluña
07 sep
Cv-Library
Cataluña
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 re
📌 Pharmacovigilance Officer (Cataluña)
🏢 Cv-Library
📍 Cataluña