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.

Minimum college diploma or degree in life science; 1-3 years experience in medical information, clinical research, or pharmacovigilance; knowledge of Health Canada, FDA, EMEA, ICH regulations; fluency in English and French; on-call duties; shift availability 8am-8pm.

Key Responsibilities

• collecting safety data
• entering data
• conducting quality reviews

Job Details

• Category: Healthcare Services - Pharmacy
• Seniority: Entry Level
• Commitment: Full Time
• Workplace: Remote — Canada
• Salary: CAD 55,000 – 65,000 / year
• Languages: English, French

About PSPSync

A provider of patient support program services with technology-enabled solutions for patients across Canada. — Industry: Healthcare