**Job Title:** Senior Manager, Safety
**Location:** Toronto, CA
**Job Type:** Permanent

**Overview:**
Reporting to the Director of Safety Operations, this role acts as the lead for the execution of Pharmacovigilance (PV) operational activities for Elvium and the wider Global Mundipharma Organization. The position drives the efficient management and delivery of all aspects of local operational activities in alignment with the vision of centralizing and globalizing the Mundipharma Pharmacovigilance system and processes within the Canada region.

**Key Responsibilities:**
- Provide PV Operations leadership for local oversight across all relevant territories, including the development and maintenance of operational documents (SOPs and Work Instructions) and contributions to Safety Management Plans.
- Manage and oversee the Global Single Intake vendor responsible for executing local operational activities, including case management, local literature monitoring, and PV training.
- Monitor compliance and performance metrics, ensuring quality and timely delivery of safety outputs by the single global intake vendor.
- Serve as the contact person for audits/inspections, ensuring inspection and audit readiness for PV operational matters.
- Collaborate with Quality Assurance (QA) to maintain an inspection-ready state.
- Contribute to the global safety team, supporting organizations in fulfilling global pharmacovigilance requirements.
- Escalate issues related to safety operations to the Director of Local Safety Operations and EEA QPPV, as appropriate.
- Drive efficient and effective delivery of PV operational activities.
- Participate in global improvement processes impacting the Global Safety Organization.

**Qualifications:**
**Education:**
- 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, particularly Module VI – Collection, management, and submission of reports of suspected adverse reactions to medicinal products (Rev 2).

**Diversity and Inclusion:**
Building 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 Elvium:**
We are a pharmaceutical company passionately committed to improving the health and quality of life of Canadians through innovative medicines for specific therapeutic disease areas. We strive to be leaders in the innovative life science space, offering treatment solutions to fill unmet medical needs. Elvium Life Sciences focuses on CNS (ADHD), cancer supportive care, and ophthalmic conditions, delivering the highest level of innovation while prioritizing the health and safety of our customers. Elvium Life Sciences is a member of the Mundipharma network of independent associated companies.

For more information, visit [www.elvium.ca](http://www.elvium.ca).