Director, UK Deputy QPPVApply Now Email Me Job ID R0015457 Date posted 01/14/2020 Location: London, United Kingdom; Paddington, United Kingdom
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future and join us at Takeda.
Join us in this key leadership role as Director, UK Deputy QPPV in our Global Patient Safety Evaluation team based from our UK Head Offices in Central London Paddington. Reporting to the UK QPPV you will be empowered to act as UK Deputy QPPV to support the function within the company and globally, ensuring compliance with the UK MHRA and other global applicable such as European PV Legislation and Regulations.
- Maintaining the company’s Pharmacovigilance (PV) system - support and deputise for the UK QPPV.
- Act as a formalised delegate for the UK QPPV and by extension other EEA non EEA Qualified Persons, as applicable.
- To delegate for the UK QPPV for other local and global activities as assigned and to be part of the backup procedure to cover the absence of the UK QPPV.
- Work closely with the EU QPPV, other Local Operating Country (LOC) PV staff and QPPVs along with global functions of GPSE and wider Takeda organisation
- Leading for UK and collaborating with Global, EU and Japan Compliance to ensure the oversight of the coordination of PV activities, PV SMEs, and PV deliverables during inspections and audits
- Developing compliance, inspections and audit procedures/processes in collaboration with the standards group and QA that reflect alignment with various regulatory authorities’ regulations (e.g. MHRA, US FDA, PMDA and EMA etc.) and implement these within the UK.
- Ensure maintenance of the Takeda Pharmacovigilance System Master File (PSMF) for UK
- Registered Nurse or Degree level qualification (e.g. Bachelors degree) or above in scientific/medical field.
- Substantial experience gained within pharmaceutical Research & Development, preferable in a Regulatory or QA function and considerable Drug Safety experience.
- Must have proven experience in PV environment with additional demonstrable experience in participating in pharmacovigilance and/or GCP audits/inspections
- Demonstrate strong leadership capability with developed skills in team building, motivating and developing people and managing within a matrix environment.
- Demonstrate in depth knowledge of regulatory agency requirements (particularly in the UK and EU) regarding drug safety and a good understanding of drug safety methodologies to meet compliance standards in signal detection and evaluation, risk/benefit assessments as well as in the implementation of pharmacovigilance planning and risk minimization strategies.
- Ability to comprehend and synthesize complex data and should have experience in the identification, analysis and implementation of programmes and procedures required to achieve corporate objectives.
- Experience of operating in a multi-disciplinary drug development and post-marketing pharmaceutical and pharmacovigilance environment and exposure to a variety of therapeutic areas.
- Excellent communicator with strong written and presentation skills.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: Competitive basic salary, Target Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance.
Empowering Our People to Shine
Learn more at takedajobs.com
GBR - London