Job Description

Accountabilities:

Perform/support PV activities, as per assigned responsibilities, which can include but are not limited to:

Ensure adherence to all relevant global and local PV processes and regulatory requirements

Ensure audit/inspection readiness at all times

Support the development and implementation of essential processes, systems, and tools for managing local PV activities according to assigned duties

Support local and global PV strategies and implementation at LOC level, as per assigned responsibilities

Support appropriate oversight of vendors/suppliers, as required 

Support local Risk Management Plans (RMPs) and risk minimization activities relevant for the territory

Where applicable, support review of protocols for local studies and define PV related processes for local / area study projects prior to their initiation, in order to ensure compliance with the pharmacovigilance requirements and company standards

Work closely with PSPV-AM China Head to support local interactions with other areas

Collaborate with Global PSPV to best support LOC needs

Embrace the Takeda cultural mind-set of “Patient, Trust, Reputation and Business” in the workplace, undertaking personal accountability to live these values as we work within our one PSPV worldwide team and represent our PSPV function inside and outside of the company, as appropriate. 

Education & Competencies (Technical and Behavioral):

Bachelor's degree required; an advanced degree in healthcare, life sciences, or medicine is preferred

Minimum of 2 years’ advanced experience in pharmacovigilance or related environments

Understanding of medical/scientific terminology

Excellent knowledge of PV regulations for the post-marketing environment and applicable legislation

Excellent written/oral communication skills (Chinese and English) and experience working within virtual teams

Execute good documentation practices

Accuracy and attention to detail

Flexible mindset

Team worker with collaborative approach 

Ability to prioritize under pressure

Well-developed organizational skills

High standard of computer literacy