Job Description: Global Pharmacovigilance Safety Coordinator We have an opportunity for a Global Pharmacovigilance Safety Coordinator. Main activities: Schedule and maintenance of the planning of all safety reports for the medicinal products and medical devices across the different geographies where Angelini is present Ensure proper coordination of safety reports preparation/submission/maintenance working in a matrix organization (indirect coordination of resources at HQ and Country level) Prepare and review pharmacovigilance and vigilance documents, including but not limited to Periodic Safety Update Reports (PSURs), Risk Management Plan (RMP), Addendum to the Clinical Overview (RMP), DSUR (Development Safety Update Report), Post Marketing Surveillance Plan (PSMP) and Report and other ad-hoc safety-related documents needed throughout the product's life cycle. Prepare the eCTD for the submission of the PSURs Ensure the safety reports submission compliance reporting to the Regulatory Authorities Prepare and coordinate safety reports responses to supplementary requests, deficiency letters, or similar Regulatory Authorities' requests received through the document assessment procedures Collect and organize any safety and applicable data requested by business partners for the preparation of safety reports, as per the applicable PV agreement Data Analysis: Analyse clinical and safety data to support the development of pharmacovigilance documents, including the evaluation of adverse events, relevant medical literature and safety signals Collaboration: Collaborate with cross-functional teams, including local pharmacovigilance manager at country level, medical experts, regulatory affairs, clinical teams, and business partner where applicable, to gather information and ensure accurate and comprehensive document content Quality Control: Conduct quality control checks to ensure accuracy, consistency, and completeness of documents, and make necessary revisions Regulatory Compliance: Ensure all documents adhere to regulatory guidelines, including ICH (International Conference on Harmonisation) guidelines, Good Pharmacovigilance Practices (GVP), EMA guidelines and any other local and extra-European requirements, as applicable Provide expertise and guidance for the development and implementation of role-relevant tools, issuing and reviewing Global and Local Standard Operating Procedures, Working instructions and templates Requirements: Bachelor's or advanced degree in life sciences, pharmacy, biology, medicine, or a related field At least 5 years of successful experience in the field of pharmacovigilance specifically within safety reports (PSUR, ACO, RMP, DSUR) management, gained in other pharmaceutical Companies In-depth Knowledge and understanding of regulatory and pharmacovigilance guidelines and requirements Scientific Acumen: Proficiency in medical and scientific terminology, as well as the ability to critically analyse clinical and safety data Fluent in English Communication Skills: Excellent written and verbal communication skills, as need to convey complex medical and scientific information clearly Collaboration: Ability to work effectively in cross-functional teams and collaborate with subject matter experts Time Management: Effective time management skills to meet tight deadlines in a regulated environment Innovative and critical thinking with performance-oriented drive We offer a permanent contract Location: Rome Angelini Pharma is an equal Opportunity Employer. We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment. #J-18808-Ljbffr
