Medical Assessment and Signal Detection Lead (MD) GPS Medical Science- ID:2006b

Role: Medical Assessment and Signal Detection Lead in pharmacovigilance, responsible for medical review, safety assessment, and signal detection of ICSRs from clinical trials and post-marketing. Responsibilities include collaboration with Medical Monitors, oversight of safety data quality, trend analysis, and preparation of safety reports (e.g., SUSAR, PSUR). The role supports regulatory responses, monitors safety regulations, and contributes to PV policy updates. Requirements: MD with 5+ years' pharma experience, expertise in safety surveillance, signal detection, and global PV regulations (FDA, EMA, ICH). High-Value: focus on drug safety, pharmacovigilance, regulatory compliance, and risk management in biopharma. Collaboration with cross-functional teams and CRO/vendor oversight is involved. Location: hybrid, preferably Palo Alto, CA, with up to 20% travel.