Patient Safety Lead

7 days ago

Toronto, Canada Takeda Pharmaceutical Full time

**OBJECTIVES**:

- Manage/lead pharmacovigilance (PV) activities and responsibilities as per LOC/cluster requirements
- Provide Pharmacovigilance expertise and support to local operating company (LOC)
- Collaborates with LOC/GPSE and internal/external key partners, where applicable
- Provides Pharmacovigilance functional expertise and support to LOCs

**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
- Supporting the development and implementation of 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
- Act as 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.

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 GPSE worldwide team and represent our GPSE function inside and outside of the company, as appropriate.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Health professional or life science degree (Bachelor’s required. Advanced degree preferred)
- Advanced experience in pharmacovigilance or related environments required (Min 5-7 years-to be customized based on country/regional situation)
- Advanced experience of working cross-functionally, preferably in R&D companies.
- Understanding of medical/scientific terminology
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
- Excellent written/oral communication skills (local language and English) and experience working within virtual teams
- Leadership skills
- Excellent collaborative skills
- Excellent organizational skills
- High standard of computer literacy

**Locations**:
Toronto, Canada
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time

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