Manager, Patient Safety

2 settimane fa

Firenze, Italia Iqvia Italia A tempo pieno

On behalf of our Client a global pharmaceutical company, IQVIA is looking for aManager, Patient SafetyMAIN TASKS AND RESPONSIBILITIESPatient Centricity & Strategic Partnership: Integrate local insights into decision-making and benefit/risk management.Collaborate with global and local teams to implement safe, compliant solutions for patient programs and commercial projects.Local Studies & Research: Provide strategic input on post-marketing surveillance, post-approval studies, Investigator Sponsored Research (ISRs), and early access programs.Oversight of local solicited programs and studies.Local Safety Expertise: Act as the local subject-matter expert for product safety.Monitor safety profiles and emerging concerns for marketed products.Compliance & Audits: Manage internal PV audits and regulatory inspections.Ensure adherence to local regulations and company standards.Risk Management: Develop and update local Risk Management Plans (RMPs) and country-specific annexes.Oversee risk minimization activities and materials.Regulatory Intelligence: Maintain expert knowledge of local PV regulations.Communicate regulatory changes and participate in industry forums.Safety Communication & Reporting: Lead local communication of safety information to authorities and stakeholders.Ensure timely submission of PSURs, signals, RMPs, PMS, and responses to health authorities.Business Integration & Leadership: Act as Patient Safety ambassador within the affiliate leadership team.Build strong business relationships to support PV strategy and forecasting.Quality Management & Training: Maintain local PV quality systems and procedures.Deliver engaging training on safety reporting and compliance.Case Management & Data Oversight: Ensure timely processing and submission of Individual Case Safety Reports (ICSRs).Manage local literature monitoring and data checks for compliance.Legal PV Role & Documentation: Serve as Local Legal PV Responsible Person.Maintain and update the Pharmacovigilance System Master File and ensure oversight of local commitments.WHO YOU AREConfirmed practical experience in pharmacovigilanceAbility to work with a high degree of autonomyComprehensive understanding of drug safety regulations and obligationsProven leadership or influencing skillsAbility to represent Company externallyExcellent communication skillsVery good written and spoken EnglishTYPE OF CONTRACTChemical Contract – starting with 1 year contractIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request.Applications WITHOUT the requirements Will NOT be fully taken into#J-*****-Ljbffr

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