Biomapas
Medical/Clinical Safety Specialist
Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist, responsible for monitoring and ensuring the safety of medicinal products during clinical trials and post-marketing phases. Requirements University degree in the Life Science field At least 5+ year's experience in Pharmacovigilance, clinical safety and clinical development Expert knowledge of pharmacovigilance legislation Knowledge of international regulations related to safety in clinical trials and postmarketing pharmacovigilance (ICH, EU GVP Modules, FDA, others) Experience working with PV databases (e.g., Veeva safety database, and/or Argus and/or ArisGlobal) MedDRA coding experience within safety databases and manual for AEs Strong computer literacy Ability to interpret and apply global drug safety regulations Fluent English language Eager to adopt automations and new technologies in daily tasks Attention to detail, time-management and problem-solving skills Benefits Professional growth and career opportunities International team and environment Bonus based on annual performance Personal accident and business trip insurance Additional health insurance Influenza vaccines Rewarding referral policy Workplace establishment allowance (fully remote) Team building, global meetings, B active events Originally posted on Himalayas