SR Director

SR Director / Director: Global Safety Operations

Location: Cambridge/UK

Department: VP Safety

Job type: Permanent

Join us and make a difference when it matters most

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

Role and Responsibilities

Reporting to VP for Safety, this role act 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 complaint 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 Management

Responsible 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)
• Act 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 Management

Business 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 fulfils obligations to contractual partners in line with PVA / SDEA.
• Acts as escalation point for Safety Agreements and vendor contract issues.
• Participate / lead global improvement processes impacting Global Case management.

Global Safety Compliance

• Establish/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 bring

• Minimum of 10 years Pharmacovigilance experience
• Sound understanding and experience of global Pharmacovigilance landscape
• Excellent management skills to deliver company and departmental goals efficiently and effectively.
• In-depth knowledge of GVP, ICH guidelines and other GxP requirements
• Demonstrated ability to work effectively and collaboratively across the organization, must have strong ability to build relationships internally and externally.
• Strong organization and problem-solving skills.
• Excellent communication and negotiation skills.
• Excellent collaborator with strong stakeholder focus.

What we offer in return

• Flexible benefits package
• Opportunities for learning & development through our varied programme
• Collaborative, inclusive work environment

Diversity and inclusion

Building 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, but also the smart 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 Mundipharma

Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit

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Additional Job Description:

Primary Location:

GB Cambridge

Job Posting Date:

Job Type:

Permanent