Associate Director Signalling Compliance - United Kingdom
·Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Quantitative Sciences)
·Ensures that Takeda Signal Detection processes and activities are compliant with EU regulations and EU regulatory authority and inspectors expectations
·Represents Pharmacovigilance and Takeda externally at a global level as an authoritative expert on signal detection processes.
·Leads training for PV and other applicable functions on signal detection processes to ensure training is implemented and compliance with processes is maintained
·Leads interactions with other PV functions including QPPV, Global Medical Safety to ensure processes are regularly updated and are fit for purpose. Leads interactions with any vendor engaged on signal detection activities
·Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with local regulations and in close liaison with the business units, including Quantitative Sciences as well as internal PV stakeholders.
·Leads interactions with other relevant functional areas both within and outside of global PV to ensure standards are maintained.
·Represents pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
·Designs and delivers relevant training as appropriate.
·Provides mentorship and guidance for junior/new pharmacovigilance scientists and aggregate safety team
·Conduct project activities for designated processes. Any other tasks assigned by manager to assist in departmental activities
- Health care background or Life Science Degree/Bachelors required; Degree in Life Sciences preferred
- Excellent document creation skills
- In depth knowledge of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis.
- Critical thinking and decision making skills
- Ability to review, analyse, interpret and present complex data to a high standard
- Global player in a global PV organisation
- Excellent communication and presentational skills
- Good level of computer literacy