Description

You will assess and interpret safety data from clinical trials, spontaneous reports, and literature, contributing to aggregate safety reports, signal detection, and risk management plans. You'll collaborate with cross-functional teams and CROs to ensure regulatory compliance and patient safety.

Requirements

• 4+ years experience in Drug Safety/Pharmacovigilance in pharma, biotech, CRO, or regulatory agency
• Degree in medical or healthcare discipline (MD, PharmD, RN, or PhD)
• Excellent knowledge of US and EU drug safety regulations, CIOMS, and ICH guidelines
• Experience with safety data collection from clinical trials, literature, and post-market
• Experience with IND/NDA submissions and regulatory authority negotiations

Responsibilities

• Generate aggregate safety reports (DSURs, PADERs, PBRERs) and provide medical input for safety documents
• Contribute to signaling and safety surveillance processes, including identification and assessment of safety signals
• Serve as medical resource for clinical trial protocols, ICFs, IBs, and Reference Safety Information
• Create and update Risk Management Plans (RMPs) and REMS
• Support medical assessment of Individual Case Safety Reports (ICSRs)