Drug Safety Associate

Detailed Job Role:

• Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management.

KRA (Key Responsibility Areas):

• Case assessment, adverse event documentation, timely reporting, risk communication

KPI (Key Performance Indicators):

• Event processing time, report accuracy, submission regularity, follow-up efficiency

• Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities.
• The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory compliance.

  Key Responsibilities:

• Monitor, collect, and document adverse event data from clinical trials or post-marketing sources
• Perform case assessments and determine seriousness, causality, and expectedness of adverse events
• Prepare and submit timely safety reports to regulatory authorities
• Assist in pharmacovigilance activities, including risk management plans and safety signal detection
• Communicate safety information to relevant stakeholders and follow up on outstanding cases
• Maintain compliance with local and international regulatory requirements (GVP, ICH-GCP)

Key Performance Indicators (KPIs):

• Timeliness of case processing and report submissions
• Accuracy and completeness of adverse event documentation
• Regularity and compliance of regulatory submissions
• Efficiency of follow-ups on safety cases

Skills & Competencies:

• Strong knowledge of pharmacovigilance guidelines and regulations (GVP, ICH, FDA, EMA)
• Attention to detail and analytical skills Effective communication and documentation skills
• Ability to manage multiple cases simultaneously
• Proficiency in safety databases (eg, Argus, ARISg) and MS Office )