Are you looking for a patient-focused,innovation-driven company that will inspireyou and empower you to shine? Join us as a Patient Safety Leadin our Torontooffice.
At Takeda, we are transforming thepharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower ourpeople to realize their potentialthrough life-changing work. Certified as a GlobalTop Employer, we offer stimulating careers,encourage innovation, and strivefor excellence in everything we do.
We foster aninclusive, collaborative workplace, in whichour global teams are united by an unwaveringcommitment to deliver Better Health and aBrighter Future to people around theworld.
Here, you will be a vital contributor to ourinspiring, bold mission.
PURPOSE: Manage pharmacovigilance (PV) activities and responsibilities related to Takeda Canada products. Provide Pharmacovigilance expertise and support to local operating company (LOC)
KEY JOB ACCOUNTABILITIES: Manages PV activities, which can include but are not limited to: Ensuring compliance to all applicable Global and local PV processes, and regulation Ensuring audit/inspection readiness at all time Developing and implementing necessary processes, systems and tools for the handling of local PV activities, as per assigned responsibilities Supporting local and global PV strategies, and implementation at LOC level, as per assigned responsibilities Be the SME, as per assigned responsibilities and as it relates to applicable global, local regulatory requirements, resourcing, compliance and other factors engaging with key local internal stakeholders, including Medical, Regulatory Affairs, Quality Assurance, commercial teams and external stakeholders (vendors, partners) with PV obligations, agreements, etc Establishing appropriate oversight of vendors/suppliers, as required Ensuring collaboration with Global GPSE to best support LOC needs. Embracing 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 GPSE worldwide team and represent our GPSE function inside and outside of the company, as appropriate.
EDUCATION, EXPERIENCE AND SKILLS Health professional or life science degree Bachelor’s required. Advanced degree preferred. Relevant pharmaceutical or health care related industry experience required Advanced experience ( 8 years minimum) in PV related environments, preferably at local level Advanced experience of working cross-functionally Understanding of medical/scientific terminology Excellent knowledge of PV regulations for the post marketing environment and applicable legislation Excellent written/oral communication skills and experience working within virtual teams Accuracy and attention to detail Flexible mindset High degree of cross-cultural awareness Team worker with collaborative approach. Ability to prioritize under pressure Well-developed organizational skills High standard of computer literacy