Pharmacovigilance Associate

Astellas Pharma - Markham, IL

Full-time - Mid Level

Markham, IL

10,001+ employees

Management of Companies and Enterprises

About the position

The Pharmacovigilance Associate at Astellas is responsible for supporting the local Drug Safety Officer (DSO) in ensuring compliance with pharmacovigilance (PV) regulations and Astellas policies. This role involves monitoring PV activities, managing case processing, and maintaining quality management systems to ensure operational excellence in drug safety practices.

Responsibilities

• Act as deputy to the local Drug Safety Officer (DSO) and perform PV activities at the local affiliate.
• Support the implementation of procedures to ensure compliance with local and regional PV regulations and Astellas policies.
• Monitor and review PV activities at the local affiliate level.
• Systematically collect and document Product Safety Information (PSI) and communicate with relevant stakeholders, including Health Authorities.
• Ensure correct case processing and quality checks in the PV database.
• Maintain appropriate tools and databases for the local PV department.
• Oversee routine reconciliations of databases with PV partners.
• Support the implementation of PV Agreements and contracts with local vendors.
• Ensure proper filing and archiving of documents according to Good Documentation Practices.
• Assist with PV Health Canada inspections and internal audits.

Requirements

• Minimum BA/BS in Health Science, Life Science, Medical Science, or equivalent experience.
• Minimum of 3 years relevant Canadian experience in Pharmacovigilance or a combination of PV/RA/QA.
• Experience with PV systems and case processing.
• Hands-on experience with maintaining (GxP) Quality Management Systems.
• Robust understanding of local PV regulations and guidelines.
• Experience with PV Processes, Standards & Training.
• Experience with preparation for PV audits and monitoring of CAPA actions.
• Proficiency in English and French.

Nice-to-haves

• Knowledge of Canada and US-FDA pharmacovigilance regulations.
• Knowledge of Drug Safety Systems, specifically Life Sphere Multivigilance.
• Experience working cross-functionally in a matrixed organization.
• Strong interpersonal skills for negotiation and consensus building.

Benefits

• Astellas Pharma Canada welcomes and encourages applications from people with disabilities.
• Accommodations are available on request for candidates during the hiring process.