Senior Manager, Safety – Mundipharma

Job Title: Senior Manager, Safety

Location: Toronto, ON

Job Description: Job Title: Senior Manager, SafetyLocation: Toronto, CAJob type: PermanentReporting to Director of Safety Operations, this role acts as lead for execution of Pharmacovigilance (PV) operational activities for Elvium and the wider Global Mundipharma Organization.Drives efficient management and delivery of all aspects of Local operational activities aligned with vision of centralizing and globalizing Mundipharma Pharmacovigilance system and processes within the Canada region.Key Responsibilities:

• Responsible for providing PV Operations leadership for conducing local oversight for all activities in all relevant territories including the development and maintenance of operational documents (SOPs and Work Instructions) and contributes to Safety Management Plans
• Responsible for management and oversight of the Global Single Intake vendor responsible in the relevant territories for executing local operational activities including but not limited to Case management, Local Literature monitoring and PV training
• Responsible for monitoring compliance and performance metrics and monitors quality and timely delivery of safety outputs by the single global intake vendor
• Act as the contact person for audits/Inspections and ensures inspection and audit readiness for PV operational matters
• Works with Quality Assurance (QA) to maintain an inspection readiness state
• A contributor to the global safety team, supports the Safety organizations in fulfilling global pharmacovigilance requirements.
• Responsible for escalating issues related to Safety operations to the Director of Local Safety Operations and EEA QPPV, where appropriate.
• Drives efficient and effective delivery of PV Operational activities.
• Participate in global improvement processes impacting Global Safety Organization

QualificationsEducation

• Life Science Graduate (minimum)
• Further Qualification in PV (preferred)

Experience

• 3-5 years in Pharmacovigilance (minimum)
• At least 3-years in PV operations (preferred)

Knowledge and Skills

• Robust knowledge of GvP modules in particular Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)

Diversity and inclusionBuilding an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients.About ElviumWe are a pharmaceutical company passionately committed to improving the health and quality of life of Canadians through innovative medicines in specific therapeutic disease areas of need and importance. We are driven to be leaders in the innovative life science space, offering treatment solutions to fill unmet medical needs for our customers. Elvium Life Sciences focuses in the areas of CNS (ADHD), cancer supportive care and ophthalmic conditions. We strive to deliver the highest level of innovation to the forefront, while keeping the health and safety of our customers a top priority. Elvium Life Sciences is a member of the Mundipharma network of independent associated companies.For more information visit

Company Name: Mundipharma

Salary:

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