Patient Safety Lead (6-months contract)

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Job Description

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 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 prioritise under pressure.
• Well-developed organizational skills.
• High standard of computer literacy.

TRAVEL REQUIREMENTS:

• minimum

Locations

Toronto, Canada

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time