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- Tasks: Lead patient safety initiatives and ensure compliance with pharmacovigilance regulations.
- Company: Join Takeda, a global leader in healthcare dedicated to patient safety.
- Benefits: Attractive salary, health benefits, flexible working options, and career development opportunities.
- Why this job: Make a real difference in patient safety while working with a passionate team.
- Qualifications: 8+ years in drug development or pharmacovigilance; strong communication skills required.
- Other info: Dynamic role with opportunities for growth and collaboration across global teams.
The predicted salary is between 48000 - 72000 £ per year.
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.
Responsibilities
- 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 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.
- 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.
- Participate in and support local operational PV activities for the UK and Ireland as needed.
- Review (as needed) 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.
- Oversee vendors, partners, and local programmes to ensure PV activities comply and do not adversely affect 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 (e.g., 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.
- Prepare and deliver PV training to Takeda employees and vendors as needed.
- Support effective PV role-based training through 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.
- 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.
- 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.
Qualifications
- 8 years+ experience of operating in a multi-disciplinary drug development or post-marketing pharmaceutical and pharmacovigilance environment with exposure to a variety of therapeutic areas.
- Strong written and presentation skills.
- Good level of computer literacy with Microsoft applications.
- Ability to successfully manage multiple tasks simultaneously.
Patient Safety Lead in City of Westminster employer: Takeda pharmaceutical
Contact Detail:
Takeda pharmaceutical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Patient Safety Lead in City of Westminster
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by researching common questions in patient safety roles. We recommend practising your answers with a friend or in front of a mirror to boost your confidence and delivery.
✨Tip Number 3
Showcase your passion for patient safety during interviews. Share specific examples from your experience that highlight your commitment to compliance and quality management in pharmacovigilance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Patient Safety Lead in City of Westminster
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Patient Safety Lead role. Highlight your experience in pharmacovigilance and compliance, and don’t forget to showcase any relevant projects or achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to express your passion for patient safety and how your background makes you a perfect fit for the role. Be sure to mention specific experiences that relate to the responsibilities outlined in the job description.
Showcase Your Skills: Don’t just list your skills; demonstrate them! Use examples from your past work to show how you've successfully managed multiple tasks, collaborated with teams, and maintained compliance in a fast-paced environment.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly!
How to prepare for a job interview at Takeda pharmaceutical
✨Know Your Pharmacovigilance Stuff
Make sure you brush up on your knowledge of UK and EU pharmacovigilance legislation. Be ready to discuss how these regulations impact patient safety and compliance, as well as any recent changes in the field.
✨Showcase Your Experience
Prepare specific examples from your 8+ years in drug development or pharmacovigilance. Highlight situations where you've successfully managed compliance issues or collaborated with cross-functional teams, as this will demonstrate your capability for the role.
✨Build Relationships
Think about how you can build effective relationships across various functions. Be prepared to discuss your approach to collaboration and how you’ve worked with stakeholders in the past to ensure compliance and operational success.
✨Be Ready for Regulatory Questions
Expect questions about regulatory intelligence and how it affects pharmacovigilance requirements. Prepare to analyse hypothetical scenarios and provide insights on how you would handle compliance challenges in the UK and Ireland.
