Pharmacovigilance Associate (Bilingual)

About PSPSync:
PSPSync Limited is a dynamic and growing provider of Patient Support Program (PSP) services, specializing in innovative, technology-enabled solutions that simplify access to therapies for patients across Canada. We are committed to delivering seamless, patient-centric support that drives outcomes for patients, healthcare providers, and our pharmaceutical partners.

PURPOSE:

The Pharmacovigilance Associate (Bilingual) 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 required.
• 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.

Please note: The Company does not use artificial intelligence in the screening, assessment, or selection of applicants for this position. This job posting relates to an existing vacancy.