Pharmacovigilance Specialist

4 days ago

Toronto, Canada LEO Pharma AS Full time

**Field of work**:Clinical Development

**Posting Date**:3 Mar 2025

**Application deadline**:
**Location**: Toronto M5K, Ontario Less CMAs, Canada
**Contract type**: Temporary
**Job ID**: 3011
Role Description**Your Role**
- As Pharmacovigilance (PV) Specialist, you will follow the strategic direction of LEO Pharma's Safety and Regulatory Affairs team, including the establishment and maintenance of globally and locally (when needed) standardized practices, to ensure compliance with international and national regulations. This role additionally supports overall corporate business strategy through tactical short and long term strategies, acknowledging local obligations and strategies, while ensuring the continuity of PV activities.
- The PV Specialist will also assume the role of deputy Safety Contact Person (dSCP), acting as a qualified health care professional assessing lack of efficacy (LOE) cases for unusual failure in efficacy (UFIE). This is a fixed term contract role, beginning May 2025 through August 2025.

**Your Responsibilities**
- Support update of Global PSMF; ensure there is a continuity plan in place
- Responsible for Pharmacovigilance (PV) interface with local health authorities
- Responsible for PV training of partners and LEO Pharma employees
- Support audit & inspections
- Bridge local to global and global to local teams by communicating transformations and changes related to the local Safety organization
- Identify and implement improvements for PV processes and procedures
- Create and update local SOPs and Wis to align with local/global legislation and company requirements
- Process safety information from spontaneous or solicited cases
- Perform reconciliation with all sources of PV cases
- Ensure regulatory reporting of cases from interventional clinical trials including development safety update report (DSUR)
- Perform regulatory surveillance of PV
- Maintain needed records
- Manage PV for PSP, MR and keep informed about IIS.
- Prepare and validate local PV contracts
- Distribute to relevant persons and alert in case of possible signals

**Your Qualifications**
- Bachelor's or Academic degree in life sciences, with a minimum of 3 years' experience in pharmacovigilance (post-marketing and clinical trials)
- Good knowledge of local and EU PV regulations Fluent English - strong oral and written communication skils**Beyond the skin**
- Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

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