Description
The Clinical Safety Manager will lead safety and pharmacovigilance activities for clinical trials, including safety budget reviews, safety management plans, SAE and SUSARS case management, safety reporting and regulatory submissions, safety database and reporting-system implementation, audits, CAPA, training, and project management. The role requires a BA/BS degree, at least 10 years of clinical safety experience, at least 5 years of pharmacovigilance experience, and knowledge of global safety regulations, MedDRA, WHODrug, and clinical-trial regulatory requirements. The position is remote and requires candidates to be legally authorized to work in the country of employment without employer sponsorship.
