Pharmacovigilance Associate

Astellas

0-2 years

Not Disclosed

Remote, USA

10 Dec. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Associate
Location: Markham, ON
Department: Pharmacovigilance
Work Schedule: Standard (Mon-Fri)

About Astellas:
At Astellas, we are committed to becoming a leading, value-driven life science innovator by transforming innovative science into value for patients. We focus on pioneering advancements and maintaining a collaborative culture, all driven by the passion of our talented people. With a rich legacy in oncology, overactive bladder, and transplant therapies, and a promising pipeline in women's health, blindness, immuno-oncology, and targeted therapies, we are committed to making a positive impact on patients' lives worldwide.

Astellas is a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 employees across approximately 70 countries. Ranked among the Top 30 global biopharma companies by revenue, Astellas is expected to be one of the Top 10 Cancer Drug Makers of 2024. As we continue to grow, we are seeking individuals who will thrive in our entrepreneurial and empowering environment.

Role Overview:
The Pharmacovigilance Associate will play a key role in supporting the local Drug Safety Officer (DSO) in pharmacovigilance (PV) activities at the Canadian affiliate. This includes ensuring compliance with both local and regional PV regulations and Astellas’ global policies. The role involves maintaining operational excellence, managing Product Safety Information (PSI), and liaising with relevant stakeholders, including Health Authorities (HA).

Key Responsibilities:

ICSR Case Intake: Ensure proper case processing and quality checks in the PV database. Monitor timelines to ensure compliance.
Local PV Quality Management: Oversee local PV tools, databases, and routine reconciliations with PV partners.
Documentation and Compliance: Support the filing, archiving, and management of documents according to Good Documentation Practices.
Regulatory Oversight: Assist with Health Canada inspections and internal PV audits, ensuring adherence to local and global regulations.
DSO Backup: Act as the backup for the local Drug Safety Officer and manage related duties as required.

Required Qualifications:

BA/BS in Health Science, Life Science, Medical Science, or a related field.
Minimum of 3 years of relevant experience in Pharmacovigilance, with experience in PV/RA/QA.
Hands-on experience with PV systems, case processing, and maintaining (GxP) Quality Management Systems.
Strong understanding of local PV regulations and experience in audit preparation and post-audit activities.
Proficiency in both English and French.

Preferred Qualifications:

Knowledge of Canadian and US-FDA pharmacovigilance regulations.
Experience with Life Sphere Multivigilance or other Drug Safety Systems.
Strong interpersonal skills with experience working cross-functionally in a matrixed organization.

Additional Information:
Astellas Pharma Canada welcomes and encourages applications from individuals with disabilities. We provide accommodations during the hiring process. Additionally, Astellas requires full COVID-19 vaccination as a condition of employment, with accommodations available under human rights legislation.

Apply Now:
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Pharmacovigilance Associate

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