OverviewOn 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.ResponsibilitiesPatient Centricity & Strategic PartnershipIntegrate 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 & ResearchProvide 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 ExpertiseAct as the local subject matter expert for product safety.Monitor safety profiles and emerging concerns for marketed products.Compliance & AuditsManage internal PV audits and regulatory inspections.Ensure adherence to local regulations and company standards.Risk ManagementDevelop and update local Risk Management Plans (RMPs) and country-specific annexes.Oversee risk minimization activities and materials.Regulatory IntelligenceMaintain expert knowledge of local PV regulations.Communicate regulatory changes and participate in industry forums.Safety Communication & ReportingLead local communication of safety information to authorities and stakeholders.Ensure timely submission of PSURs, signals, RMPs, PMS, and responses to health authorities.Business Integration & LeadershipAct as Patient Safety ambassador within the affiliate leadership team.Build strong business relationships to support PV strategy and forecasting.Quality Management & TrainingMaintain local PV quality systems and procedures.Deliver engaging training on safety reporting and compliance.Case Management & Data OversightEnsure timely processing and submission of Individual Case Safety Reports (ICSRs).Manage local literature monitoring and data checks for compliance.Legal PV Role & DocumentationServe 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 contract
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