Pharmacovigilance Scientist

Advanced degree in life sciences (e.g., PharmD, PhD) or related field Minimum of 3 years of experience within the pharmaceutical industry, ideally including drug safety experience Knowledge of good pharmacovigilance practices, drug safety regulations, and clinical trial processes Understanding of pharmacovigilance regulatory practices including CIOMS, EMA, ICH and FDA guidelines Experience with adverse event data review, safety signal detection, and safety database management (e.g. Argus, MedDRA, Veeva Vault) Strong analytical, communication and presentation skills Strong organizational and project management skills Ability to collaborate effectively across multidisciplinary teams

Collects, reviews, and analyzes adverse event reports Supports quality control review of individual case safety reports (ICSRs) Assists in ongoing safety monitoring activities Supports safety data management activities Assesses clinical safety data to identify, evaluate, and document adverse events Contributes to risk-benefit analyses and supports risk mitigation strategies Supports the preparation and review of pharmacovigilance documents Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations Conducts literature reviews and safety signal assessments Works closely with cross-functional teams Supports compliance with global pharmacovigilance regulations Supports communication and oversight of pharmacovigilance vendors Supports the project management of safety activities