Pharmacovigilance and Medical Information Associate

Pharmacovigilance and Medical Information Associate

Pharmacovigilance Associate will provide service to both external customers and also support internal management.

Job Description & Key Responsibilities

• Triage and evaluate ICSR reports for validity, seriousness and reportability.
• Prepare and submit adverse event reports (CIOMS) to partner and Health Canada as per Pharmacovigilance agreement in a timely manner.
• Conduct causality assessments for safety case reports and liaise with Global Safety Officer and partners for improvement in product safety.
• MedDRA coding assessment.
• Evaluate pharmacovigilance reports and maintain a pharmacovigilance system.
• Selecting and screening of journals for performing literature searches for adverse events.
• Screening Canada Vigilance Database for retrieval of the ICSR reports for company products and reporting to Health Canada and partners as per PV agreement and He...