Pharmacovigilance Coordinator

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. 

POSITION SUMMARY:

The Pharmacovigilance Coordinator is responsible for managing clinical information, ensuring accurate documentation, and supporting drug safety activities. Key duties include mailbox management, data entry, document review, communication with clients, and supporting quality checks. The role may involve on-call duties and other tasks as needed to support pharmacovigilance operations. 

This position requires a highly organized, analytical, and detail-oriented individual with strong communication and cross-functional collaboration skills. The role is typically full-time, with shifts scheduled between 8:00 AM and 8:00 PM, including potential on-call responsibilities. 

PRIMARY DUTIES AND RESPONSIBILITIES: 

Patient Data and Document Management

Review patient information for accuracy and completeness

Attach and review source documents to ensure proper documentation

Sort, file, and maintain organized records of incoming documents and faxes

Data Entry, System Updates, and Mailbox Coordination

Enter data accurately into databases and quality systems, including safety databases as applicable

Manage email correspondence and mailbox for communication and follow-ups

Quality Assurance and Safety Report Review

Perform quality checks on adverse event reports

Conduct reconciliation activities and follow-up with stakeholders

Translation and Communication Support

Assist in document translation (written and verbal) to support clear communication and documentation accuracy 

Additional Duties and Responsibilities:

Be available for on-call duties as required, including evenings and weekends if necessary

Perform other tasks and responsibilities as assigned periodically

Willingness to work flexible shifts between 8:00 AM and 8:00 PM, including potential after-hours and weekend work

EXPERIENCE AND EDUCATIONAL REQUIREMENTS: 

Educational Background: Minimum college diploma or degree in a Life Science discipline such as biology, chemistry, pharmacology, or related field. A university degree is preferred.

Professional Experience: Experience in Medical Information, Clinical Research, Pharmacovigilance, or related industry fields is an asset. Candidates with relevant transferable skills will also be considered.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: 

Industry Knowledge: Familiarity with pharmacovigilance guidelines, including Health Canada, US FDA, EMEA, and ICH regulations, is an asset.

Technical Skills: Proficiency in MS Office applications (Word, Excel, Outlook). Experience with safety databases (e.g., Argus, ARISg) or similar tools is an asset.

Language Skills: Fluency in written and verbal English is required; proficiency in French (written and spoken) is an asset.

Medical Terminology: Knowledge of 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.

Adaptability: Willingness to adapt to changing work environments and learn new skills as required.

Self-Management: Ability to work independently in a self-directed manner within a structured environment.

ESSENTIAL SKILLS

Fluency in both English and French (written and oral) is an asset

Good communication and teamwork skills

Attention to detail and accuracy in a fast-paced environment

Commitment to continuous learning and professional growth

Ability to work independently and manage time effectively

Note: 

This role involves handling sensitive patient information and requires strict adherence to confidentiality and data privacy regulations. 

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.