Pharmacovigiliance

Roles and Responsibilities :

• Conduct thorough case processing, medical summarization, and signal detection to identify potential safety signals from adverse event reports.
• Collaborate with cross-functional teams to investigate and resolve issues related to drug safety.
• Provide expert advice on pharmacovigilance strategies and best practices to internal stakeholders.
• Develop and maintain accurate records of all safety-related activities, ensuring compliance with regulatory requirements.

Job Requirements :

• 2-19 years of experience in pharmacovigilance or a related field (e.g., clinical trials management).
• Strong understanding of drug safety principles, regulations (e.g., ICH E2C), and industry standards (e.g., FDA guidelines).
• Proficiency in ADR reporting tools such as MedDRA coding system; knowledge of other relevant terminologies an asset.
• Excellent analytical skills for managing large datasets, identifying trends, and developing actionable insights.