12 month contract
Remote - UK based
Inside IR35

Brief Description
The purpose of this role is to support to the EU/International PV & QPPV Office team in promoting, maintaining, and improving compliance with the applicable regulatory and/or legal pharmacovigilance (PV) obligations in the EU and in International (INT) Territories where the company operates.

Support the EU/International PV & QPPV Office team to guarantee the PV system oversight.

Provide oversight and input for PV activities in all global expansion activities, including detection of relevant information related to Countries, Affiliates (if applicable) and PV Partners.

Work closely with Global Regulatory Affairs and Drug Safety colleagues to promote, maintain and improve oversight of Global Expansion activities management and local QPPVs in EU/Int Territories in compliance with the applicable regulatory PV requirements in EU/Int Territories where the company operates.

Ensure that the EU/Int PV & QPPV Office is informed of any progress relevant to geographical expansion.

Act as Pharmacovigilance System Master File (PSMF) Administrator with the aim to support the management of the EEA company PSMF and local PSMFs or equivalent document in EU/INT Territories.

The Senior Manager is responsible for maintaining up to date regulatory knowledge of PSMF requirements, for providing training on PSMF, as required, and proposing strategies for the process improvement of development, preparation and maintenance of different PSMFs in EU and INT Territories.

Essential Functions
Serve as the PSMF Administrator/back-up for the PSMFs or equivalent documents:
• Coordinate the preparation and ongoing maintenance of the PSMFs or equivalent documents, and the related documentation, in accordance with the assigned schedule
• Coordinate the ad hoc preparation of Summaries of PV system
• Maintain schedule of updates and data requirements for the PSMFs or equivalent documents
• Ensure the content of the PSMFs, or equivalent documents, are compliant vs GVP Module II requirements by liaising with key contributors from all relevant global functions and/or with the Local applicable PV regulations
• Ensure the content of the PSMFs, or equivalent documents, are provided in a timely manner, collating the data, resolving queries and ensuring review, approval and release of the document as appropriate and per applicable procedures

Upload completed PSMF releases and Summaries of PV system into the electronic Quality Management System (eQMS) and ensure relevant documentation is archived in accordance with company requirements;
• Ensure that the QPPV/Deputy are made aware of significant changes and updates of the PSMFs, or equivalent documents, content and/or format on an ongoing basis
• Ensure appropriate and up-to-date procedural documents are in place for the maintenance of the PSMFs or equivalent documents
• Perform other PSMF-related activities, as appropriate

Ensure oversight of activities and interactions with internal departments and external business partners (e.g. affiliates, distributors, marketing partners, third party service providers), including but not limited to:
• Represent the EU/International PV & QPPV Office team in meetings, when required
• Set up meetings, prepare agendas and minutes, when required

Provide support to Geographic Expansion activities, including but not limited to:
• Management and implementation of change controls and actions plans for PV activities
• Management of periodic meetings with international regulatory staff
• Management of periodic oversight meetings with local QPPVs and PV Partners
• Perform other Geographic Expansion-related activities, as appropriate

Provide support to the EU/International PV & QPPV Office for PV audits and inspections, including:
• Assisting with the readiness, preparation, facilitation and follow-up of PV audits and inspections
• Assisting with the development, management & implementation of corrective & preventative actions (CAPAs) arising from PV audits and inspections
• Functioning as subject matter expert for audit/inspections interviews
• Provide input on procedural/non-procedural documents relevant for the EU/International PV & QPPV Office.

Provide input on procedural/non-procedural documents relevant for the EU/International PV & QPPV Office team.

Provide support for other EU/International PV & QPPV Office team related activities, as appropriate.

Required Knowledge, Skills, and Abilities
• 4+ years of experience in Senior Manager role in PV
• Good knowledge of EU/International pharmacovigilance regulations
• Excellent PV system oversight capability
• Strong planning, tracking and coordination skills
• Excellent interpersonal and communication skills, both written and verbal, and fostering effective collaborations across departments
• Fluent in English, both written and spoken
• Able to identify and implement process improvements
• Able to work on multiple tasks simultaneous with limited supervision
• Technical understanding of audit preparation and dealing with CAPAs
• Ability to review service provider contracts, and work effectively with service providers.
• Excellent knowledge of Microsoft Word, Excel and PowerPoint; ability to learn to use other applications, as required

Required/Preferred Education and Licenses
• Life Science or pharmacy degree preferred
• Experience in Pharmacovigilance or R&D Quality required
• Experience working closely with or within a QPPV function preferred but not essential