Job Description

PURPOSE:

The Pharmacovigilance Associate is responsible for collecting, verifying, and reporting

safety data related to adverse events, ensuring data accuracy and compliance with

industry regulations. They support quality assurance, conduct risk analyses, manage

communications, and maintain documentation to ensure the safety and integrity of

pharmacovigilance activities.

PRIMARY DUTIES AND RESPONSIBILITIES:

Key Duties and Responsibilities:

Safety Reporting: Collect, verify, and analyze adverse event reports, product

complaints, and other safety information from patients, clinics, and healthcare

professionals, and submit them to pharmaceutical companies within tight

deadlines.

Data Entry: Enter safety event data into program-specific databases, ensuring

accuracy and completeness.

Quality Assurance: Ensure the quality of safety events data, conduct quality

reviews, and identify areas for improvement.

Communication: Manage incoming communications from multiple sources,

respond to inquiries, and file documents according to Good Documentation

Practices.

Quality Investigations: Assist in conducting root cause analyses (RCAs) and

executing corrective action and preventive action (CAPA) plans for quality

discrepancies.

Reconciliation: Conduct regular reconciliations with internal and external parties to

ensure accuracy and compliance with agreements.

Documentation: Maintain accurate and consistent patient records and related

documents in accordance with Good Documentation Practices.

Additional Duties and Responsibilities:

Be available for on-call duties as required. Perform other tasks and responsibilities as assigned periodically. Willing to work any 8-hour shift between 8:00 AM and 8:00 PM, as needed.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS

Educational Background: Minimum college diploma or degree in a Life Science

discipline, such as biology, chemistry, or pharmacology, is strongly recommended.

Professional Experience: A minimum of 1-3 years of experience in Medical

Information, Clinical Research, or Pharmacovigilance, or a related field within the

pharmaceutical industry.

Industry Knowledge: Familiarity with Pharmacovigilance industry guidelines,

including Health Canada, US FDA, EMEA, and ICH regulations, is essential.

Adaptability: Willingness to adapt to changing work environments and learn new

skills as required.

Multilingualism: Proficiency in both English and French is an asset, with the ability

to communicate effectively with clients and stakeholders.

Medical Terminology: Familiarity with medical terminology and coding systems is

beneficial.

Communication Skills: Strong verbal and written communication skills, with the

ability to work effectively in a team environment.

Technical Skills: Proficiency in basic computer skills, including software

applications relevant to the industry.
Fluency in written and verbal English and French is an asset Good communication and teamwork skills Ability to work effectively in a detail-oriented environment Proficiency in medical terminology and coding systems Demonstrates a commitment to continuous learning and professional development Seeks opportunities for self-improvement and growth in their role * Possesses a suitable independent/self-directed work environment