Pharmacovigilance Associate

3 weeks ago

Oakville, Canada XEDITON PHARMACEUTICALS INC Full time

**Company Description**:
Xediton is a small privately held pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. We are located in Oakville, Ontario.

**Pharmacovigilance Associate**

**Job Description & Key responsibilities**:
The **Pharmacovigilance Associate **will provide service to both external customers and also support internal management.

**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

**Skills & Qualification**

**Educational Qualification**

University Science Degree with at least three years of previous Pharmacovigilance 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

**Salary**: $50,000 to $55,000
- **If this opportunity is of interest to you and are looking to working in a small company with growth opportunities, we would like to speak to you**_.

**No agencies, please.**

**Salary**: $50,000.00-$55,000.00 per year

**Benefits**:

- Dental care
- Disability insurance
- Extended health care
- Life insurance
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Oakville, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

- This is an office based role. Are you able to work form the office? Yes or No

**Education**:

- Bachelor's Degree (required)

**Experience**:

- PV: 3 years (required)

Work Location: One location

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