Pharmacovigilance Associate

**Vacancy Overview**

The Pharmacovigilance Associate will provide service to both external customers and also support internal management.

**Company Description**
- Xediton is a small privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. We are committed to developing, partnering and making available new and established medicines to promote the health of Canadians. We are located in Oakville, Ontario
- Department:

- **Pharmacovigilance**
- Project Location(s):

- **Oakville, ON**
- Education:

- **University Science Degree**
- Salary:

- **50,000-55,000**
- Job Type:

- **Full Time**

**Skills & Experience**

Competencies:

- Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
- Knowledge of Canadian GMPs and Pharmacovigilance
- Applies good document management practices.
- Solid working knowledge of Pharmacovigilance
- Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
- Excellent communication skills (written and oral)
- Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
- Self-starter who is able to work independently with mínimal supervision

Minimum Qualifications:

- University Science Degree with at least three years of previous Pharmacovigilance experience

**Responsibilities**

Specific responsibilities include:

- Triage and evaluate ICSRs for validity, seriousness and reportability.
- Prepare and submit adverse event reports (CIOMS) to partner and Health Canada as per Pharmacovigilance agreement in a timely manner
- Conduct causality assessments for safety cases reports and liaise with Global safety officer and partners for improvement in product safety.
- MedDRA coding assessment
- Evaluate pharmacovigilance reports and maintain a pharmacovigilance system
- Selecting and screening of journals for performing Literature searches for adverse events.
- Screening Canada Vigilance Database for retrieval of the ICSRs for company products and reporting to Health Canada and Partners as per PV agreement and Health Canada Guidelines.
- Performing Reconciliation with Business partners as Pharmacovigilance Agreements
- Identifying and reporting Unusual failures in efficacy reports to Health Canada.
- Assist in the preparation, review and evaluation of signals, aggregate reports (PSUR and PBRER) risk management plan as per Product requirements.
- Generate responses to regulatory authority requests on product safety related issues for marketed products or products in development.
- Support in preparing for PV inspections and audits as required and execute necessary corrective actions
- Conduct medical reviews for all documents and assess them for scientific validity and accuracy
- Ensure clinical and scientific information provided is accurate, fair, balanced and based on current medical literature and practice
- Conduct literature reviews and summarize complex evidence; assist with educational resources for HCPs
- Coordinating and preparing product and disease state training for different audiences
- Support Business Development in product evaluation and assessment; review all sales and marketing material for scientific accuracy

**Salary**

**Salary**: $50,000 to $55,000