Senior Patient Safety Lead (UK & Ireland)

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Job Description

Are you passionate about patient safety and pharmacovigilance compliance? Takeda’s Patient Safety & Pharmacovigilance (PSPV) organisation is looking for a Senior Patient Safety Lead to support the UK QPPV in ensuring the UK Pharmacovigilance (PV) system remains compliant with relevant PV legislation and guidance, while also providing operational PV support across the UK and Ireland Local Operating Company.

OBJECTIVE:

• Support the UK QPPV in maintaining UK PV system compliance with UK PV legislation and relevant EU guidance.
• Maintain a strong working knowledge of global PV legislation, regulations, and guidelines, with a particular focus on the UK and EU.
• Support and/or perform operational LOC PV activities for the UK and Ireland.
• Collect, analyse, and interpret regulatory intelligence impacting UK and Ireland PV requirements and advise on implications for the UK PV/EU system.
• Ensure the maintenance of the UK Pharmacovigilance System Master File (PSMF).
• Provide back-up support to the UK QPPV in their absence.
• Build effective relationships across the UK/Ireland LOC functions and Takeda PSPV global functions to support with UK PV system compliance.
• Collaborate with Global, and EU stakeholders to ensure the coordination of PV activities, PV SMEs, and deliverables during inspections and audits.

ACCOUNTABILITIES:

PV system maintenance, governance, and cross-functional collaboration

• Analyse and interpret regulatory information regarding pharmacovigilance requirements in the UK and Ireland.
• Help maintain a robust local quality management system, including the review of local SOPs, change control assessments and quality event/deviation management.
• Collaborate across PSPV, Regulatory Affairs, and Quality teams (global, regional, and country level) to identify and resolve issues impacting the UK PV system.
• Work with regional/global PSPV compliance teams to provide oversight of UK compliance metrics.
• Escalate PV issues and risks to senior management when required.

Safety deliverables and operational PV support

• Support and/or perform local operational PV activities for the UK and Ireland.
• Participate in the review (as needed) of UK Risk Management Plans (RMPs), periodic aggregate safety reports (PSURs/PBRERs), PASS, and ad-hoc safety reports.
• Provide input to urgent UK/EU regulatory actions, audits, and inspections, ensuring appropriate internal information-sharing.
• Lead on the LOC implementation of new or updated additional risk minimisation materials for the UK and Ireland.
• Support medical safety and product-related safety topics and provide input on product quality issues/incidents to the UK QPPV/PSPV.
• Provide input to Health Authority query responses to ensure timely management and resolution.

Oversight of vendors, partners, and local programmes

• Ensure oversight and compliance of business partners and/or vendors delegated or outsourced to perform PV activities that could impact the UK and/or global PV system.
• Ensure local market research and patient support programmes manage safety information as per company procedures and legislative requirements.
• Inform PSPV of local third-party agreements (for example, in-licensing or out-licensing) and support appropriate PV oversight.
• Review protocols for local non-interventional studies to ensure compliance with local PV requirements and company standards, prior to initiation.

Training and inspection readiness

• Prepare and deliver PV training to Takeda employees and vendors as needed.
• Support effective PV role-based training through the establishment and monitoring of PV training matrices in collaboration with global/local quality teams.
• Support inspection and audit activities as needed, including providing direct support to the UK QPPV.

UK PSMF production/review

• Contribute to the UK PSMF schedule and the training of PSMF contributors.
• Assist with/ensure preparation of full versions of the UK PSMF and Annexes.
• Assist with/ensure archival of submitted versions in designated repository.
• Coordinate staff in Global PSPV, EU QPPV office and LOCs with the production of the UK PSMF in response to a request from the MHRA.

Business continuity/UK QPPV back-up

• Provide back-up support to the UK QPPV during absence to ensure 24/7 coverage for PV queries arising from Global PSPV, the LOC, MHRA or other sources.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Demonstrateindepthknowledgeofregulatoryagencyrequirements(particularlyinthe UK and EU). Abilitytocomprehendandsynthesisecomplexdataandshouldhaveexperienceinthe identification, analysis and implementation of programmes and procedures required to achieve corporate objectives.
• 8 years+ experience of operating in a multi-disciplinarydrug development or post-marketing pharmaceutical and pharmacovigilance environment with exposure to a variety of therapeutic areas.
• Strongwrittenandpresentationskills
• GoodlevelofcomputerliteracywithMicrosoftapplications.
• Abilitytosuccessfullymanagemultipletaskssimultaneously.

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