Senior Manager, Safety Cluster Lead

Key Responsibilities

• Pharmacovigilance Operational Leadership
• Provide leadership and oversight for local Pharmacovigilance operational activities across assigned territories.
• Ensure appropriate implementation and maintenance of safety processes, SOPs, work instructions, and operational documentation.
• Contribute to the development and maintenance of Safety Management Plans.
• Support the execution of global and local PV requirements in alignment with regulatory expectations and company standards.
• Drive execution excellence across all PV operational activities.
• Vendor Management & Operational Oversight
• Manage and oversee Pharmacovigilance intake vendors responsible for local safety activities.
• Ensure effective delivery of: Individual Case Safety Report (ICSR) management Local literature monitoring Pharmacovigilance training activities Additional local PV operational requirements
• Monitor vendor performance through established KPIs and compliance metrics.
• Ensure quality, accuracy, and timeliness of all safety deliverables.
• Escalate performance concerns and implement corrective actions where necessary.
• Compliance, Inspection & Audit Readiness
• Act as the primary point of contact for Pharmacovigilance operational audits and regulatory inspections.
• Partner closely with Quality Assurance to maintain continuous inspection readiness.
• Ensure CAPA actions are appropriately managed and implemented.
• Support internal and external audits and contribute to regulatory responses when required.
• Promote a culture of quality and compliance across all safety operations.
• Global Safety Collaboration
• Serve as an active member of the Global Safety organization.
• Collaborate with Global Case Management, Safety Systems, Safety Evaluation, Safety Compliance, and Clinical Safety teams.
• Support the achievement of organizational goals and Pharmacovigilance compliance objectives.
• Escalate operational and compliance risks appropriately to the Director, Safety Operations and EEA QPPV.
• Ensure effective communication of key safety operational issues and resolutions.
• Process Improvement & Operational Excellence
• Participate in global initiatives aimed at improving safety systems, processes, and operating models.
• Identify opportunities to optimize workflows, enhance compliance, and improve operational efficiency.
• Support implementation of process improvements impacting the Global Safety organization.
• Contribute to the development of a high-performing, globally integrated PV function.
• What We're Looking For
• Essential Qualifications
• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline.
• Additional qualification or specialization in Pharmacovigilance, Drug Safety, or Regulatory Affairs is highly desirable.
• Strong understanding of international Pharmacovigilance regulations and requirements.
• Fluent English communication skills, both written and verbal.

Experience

• Minimum 3-5 years of experience in Pharmacovigilance.
• Preferably at least 3 years of experience in Pharmacovigilance Operations.
• Experience managing outsourced PV activities and vendor relationships.
• Experience supporting health authority inspections and audits.
• Exposure to global Pharmacovigilance environments and multinational operations.
• Experience working within GxP-regulated environments.
• Strong knowledge of Good Pharmacovigilance Practice (GVP) requirements.
• Robust understanding of GVP Module VI: Collection, Management and Submission of Reports of Suspected Adverse Reactions.
• Solid understanding of safety case processing and regulatory reporting requirements.
• Strong vendor management and performance monitoring capabilities.
• Excellent problem-solving and decision-making skills.
• Strong project management and organizational abilities.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities in a complex global environment.
• High attention to detail and commitment to quality and compliance.
• Key Stakeholder Relationships
• Internal Stakeholders
• VP Safety
• EU QPPV
• Director, Safety Operations
• Director, Global Safety Evaluation
• Director, Safety Compliance & Alliance Management
• Director, Clinical Safety Evaluation
• Director, Global Case Management & Safety Systems
• Regulatory Affairs Teams
• Quality Assurance Teams
• Medical Affairs Teams
• External Stakeholders
• Pharmacovigilance Service Providers
• Safety Intake Vendors
• Regulatory Authorities
• External Auditors and Inspectors
• Strategic Safety Partners
• What You'll Gain
• At Mundipharma, you'll join a global organization dedicated to protecting patient safety through innovation, operational excellence, and scientific rigor.
• Competitive compensation and benefits package
• Opportunities for global career growth and development
• Exposure to international Pharmacovigilance and safety operations
• A collaborative and purpose-driven culture
• Meaningful work that directly impacts patient safety worldwide
• Opportunities to contribute to global transformation initiatives within Safety
• Essential Qualifications
• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related scientific discipline.
• Additional qualification or specialization in Pharmacovigilance, Drug Safety, or Regulatory Affairs is highly desirable.
• Strong understanding of international Pharmacovigilance regulations and requirements.
• Fluent English communication skills, both written and verbal.

Knowledge & Skills

• Strong knowledge of Good Pharmacovigilance Practice (GVP) requirements.
• Robust understanding of GVP Module VI: Collection, Management and Submission of Reports of Suspected Adverse Reactions.
• Solid understanding of safety case processing and regulatory reporting requirements.
• Strong vendor management and performance monitoring capabilities.
• Excellent problem-solving and decision-making skills.
• Strong project management and organizational abilities.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities in a complex global environment.
• High attention to detail and commitment to quality and compliance.
• Key Stakeholder Relationships
• Internal Stakeholders
• VP Safety
• EU QPPV
• Director, Safety Operations
• Director, Global Safety Evaluation
• Director, Safety Compliance & Alliance Management
• Director, Clinical Safety Evaluation
• Director, Global Case Management & Safety Systems
• Regulatory Affairs Teams
• Quality Assurance Teams
• Medical Affairs Teams
• External Stakeholders
• Pharmacovigilance Service Providers
• Safety Intake Vendors
• Regulatory Authorities
• External Auditors and Inspectors
• Strategic Safety Partners
• What You'll Gain
• At Mundipharma, you'll join a global organization dedicated to protecting patient safety through innovation, operational excellence, and scientific rigor.
• We offer:
• Competitive compensation and benefits package
• Opportunities for global career growth and development
• Exposure to international Pharmacovigilance and safety operations
• A collaborative and purpose-driven culture
• Meaningful work that directly impacts patient safety worldwide
• Opportunities to contribute to global transformation initiatives within Safety

About Mundipharma