SR Director

OverviewSR Director / Director: Global Safety Operations at Mundipharma. Location: Cambridge/UK. Department: VP Safety. Job type: Permanent.Join Mundipharma to apply for the SR Director / Director: Global Safety Operations role. Mundipharma is a global healthcare company focused on bringing innovative treatments to patients. We are headquartered in Cambridge, UK, with a focus on delivering for patients, healthcare professionals, partners, and employees.Role and ResponsibilitiesReporting to VP for Safety, this role acts as lead for development and delivery of operational governance structure in the management of global strategy for Mundipharma Global Case Management, Safety Agreements framework with third parties with the goal to develop capabilities and resources required to enable an efficient and compliant management of relevant processes. Expand the reach and impact of the Safety function by building enterprise knowledge to ensure Safety compliance risks and vulnerabilities are adequately understood, effective mitigations are in place and actions are adequately communicated.Global Case ManagementResponsible for providing PV Operations leadership for case management of safety information from both clinical trials and post-marketing setting.Authors governing operational documents (SOPs and Work Instructions) and contributes to Safety Management Plans. Responsible for providing oversight to the vendor responsible for case management while ensuring compliance with Mundipharma global procedures and independent associated companies and third-party contractual agreements.Provides direction and oversight to case management vendor to ensure compliance with GVP and acts as point of contact for case management.Responsible for monitoring compliance and performance metrics and monitors quality and timely delivery safety outputs by case management vendor.Assists case management vendor with investigating reasons for late cases and providing corrective and preventative action (CAPA).Acts as the contact person for audits/Inspections and ensures inspection and audit readiness for PV Case Management.Works with Quality Assurance (QA) to maintain an inspection readiness state.A member of Safety Leadership supports the Safety organizations in fulfilling global pharmacovigilance requirements.Responsible for escalating issues related to case management to the VP of Safety and EEA QPPV.Drives efficient and effective delivery of PV Operational activities, predominately associated with case processing.Alliance ManagementBusiness Process Owner for Third Party Safety partnerships. Providing strategic direction to ensure effective and compliant PVA/SLA/SDEA delivery.Proactively develops templates and implements tools and methods used in the oversight of Safety agreement obligations and partner performance in line with strategic goals set by the organization.Leads and provides significant strategic contributions to Safety due diligence/business development activities related to potential alliance partnerships as required.Collaborates with the Safety sub-functional areas to ensure Mundipharma fulfills obligations to contractual partners in line with PVA / SDEA.Acts as escalation point for Safety Agreements and vendor contract issues.Participates / leads global improvement processes impacting Global Case management.Global Safety ComplianceEstablish/maintain the Mundipharma Research Quality Systems related to Pharmacovigilance (PV) and Vigilance in accordance with relevant (national and international) legislation and GxP requirements.Work in close cooperation with the European QPPV and stakeholders to maintain the Mundipharma Safety system and ensure that all data and documents needed for QPPV and Safety leadership oversight are made available.Establish/maintain Safety Compliance and Performance indicators to report on the effectiveness of the Mundipharma Safety System. Chair Safety Compliance meetings.Collaborate with Safety leadership to establish/maintain the vendor oversight strategy (KPIs) related to Pharmacovigilance (PV) and Vigilance outsourced services.Provide leadership to support root cause analysis/appropriate CAPA delivery for Safety non-compliance issues.Ensure Safety Leadership has oversight of Safety non-compliance issues.Lead audit/inspection readiness activities to ensure the Mundipharma Safety team is audit/inspection ready including the development of successful and timely responses to CAPAs.Establish/maintain a global Safety training matrix to enable oversight of training requirements within Global Safety.Collaborate with Quality to ensure training needs are met using the learning management system.What You’ll BringMinimum of 10 years Pharmacovigilance experienceSound understanding and experience of global Pharmacovigilance landscapeExcellent management skills to deliver company and departmental goals efficiently and effectivelyIn-depth knowledge of GVP, ICH guidelines and other GxP requirementsDemonstrated ability to work effectively and collaboratively across the organization, must have strong ability to build relationships internally and externallyStrong organization and problem-solving skillsExcellent communication and negotiation skillsExcellent collaborator with strong stakeholder focusWhat We Offer In ReturnFlexible benefits packageOpportunities for learning & development through our varied programmeCollaborative, inclusive work environmentDiversity and InclusionBuilding an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.About MundipharmaMundipharma is a global healthcare company focusing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. We are dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com.Join our talent poolIf you’re not sure this role is right for you but you’d like to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.Additional Job DescriptionPrimary Location: GB CambridgeJob Posting Date: 2025-10-20Job Type: PermanentSeniority levelDirectorEmployment typeFull-timeJob functionBusiness Development and SalesIndustriesReferrals increase your chances of interviewing at Mundipharma by 2xGet notified about new Director Global Operations jobs in Cambridge, England, United Kingdom.Greater Bristol Area, United Kingdom 1 week ago #J-18808-Ljbffr