Manager, Patient Safety

4 settimane fa

Bardi PR, Italia IQVIA Italia A tempo pieno

Overview On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Manager, Patient Safety who can join an exciting working environment in a dynamic atmosphere areas. Responsibilities Patient 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 ARE Confirmed practical experience in pharmacovigilance Ability to work with a high degree of autonomy Comprehensive understanding of drug safety regulations and obligations Proven leadership or influencing skills Ability to represent Company externally Excellent communication skills Very good written and spoken English TYPE OF CONTRACT Chemical Contract – starting with 1 year contract J-18808-Ljbffr

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