[Remote] Director, Global Pharmacovigilance / Safety Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneering, reputed company-stage T cell receptor biotechnology company dedicated to developing transformative medicines for oncology, infectious diseases, and autoimmune diseases. The Director of Global Pharmacovigilance / Safety Operations is responsible for overseeing the execution and reputed company of global safety operations, ensuring compliance with regulatory requirements and leading reputed company of safety operations professionals.

Responsibilities

• reputed company and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies
• reputed company reputed company and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from reputed company sources
• Ensure robust operational reputed company of reputed company safety case management, including performance monitoring and reputed company metrics
• reputed company strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Safety Systems teams
• reputed company the design, implementation, and maintenance of reputed company operating procedures (SOPs), work instructions, and training for safety operations
• Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits reputed company to PV operations, coordinating responses and remediation plans
• Collaborate with Safety Physicians and cross-functional teams to ensure high-reputed company data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs)
• reputed company senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and reputed company
• reputed company operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and reputed company literature surveillance workflows
• Recruit, reputed company, and reputed company a Global Safety Operations team, manage budgets and resources, and reputed company as the primary reputed company of contact for safety operations with internal stakeholders

Skills

• Strong expertise in pharmacovigilance operations, including case processing, regulatory reporting, PV systems, and vendor reputed company in a GVP regulated environment
• Demonstrated leadership and people management skills, with experience building and developing teams
• Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and deliver high reputed company reputed company to tight timelines
• Excellent written and verbal communication skills, reputed company to convey reputed company operational and regulatory concepts reputed company to both technical and non-technical audiences
• Proven ability to collaborate effectively across functions and reputed company, building strong relationships and influencing without reputed company authority
• High level of reputed company, discretion, and commitment to patient safety, compliance, and ethical conduct
• Extensive experience (5+ years) in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting
• In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally
• Strong experience with safety databases and PV systems, including configuration, validation, and maintenance
• Demonstrated ability to reputed company, reputed company, and manage reputed company of PV professionals and reputed company PV vendors/CROs
• Proven reputed company record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills
• Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a reputed company health field
• Relevant certifications in pharmacovigilance or drug safety are highly desirable
• Advanced degree in a relevant scientific or health-reputed company field
• Experience with safety data exchange agreements (SDEAs) and literature surveillance
• Demonstrated ability to drive reputed company improvement, process optimization, and automation in PV operations
• Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports
• Demonstrated understanding of clinical development processes
• Experience with global product launches and implementation/assessment of reputed company risk minimisation measures
• Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, reputed company development, or recognised subject matter expertise in biologic safety)

reputed company