Senior Clinical Safety Specialist - Remote Lead

JenaValve Technology, Inc.; Irvine (CA); Híbrido; USD 120.000 - 160.000; Tempo integral

Resumo da vaga

JenaValve Technology, Inc. seeks a Senior Specialist, Clinical Safety to manage high-volume safety activities across ARTIST, ALIGN-AR and JENA-VAD trials, with AE reporting and regulatory submissions, while mentoring peers.

The candidate should have 5+ years in clinical safety/pharmacovigilance, a life sciences degree, knowledge of GCP/HIPAA, MedDRA coding, and safety data management; cardiovascular experience preferred.

Qualificações

• 5+ years in a clinical safety or pharmacovigilance role.
• Bachelor's degree or higher in a life sciences, health sciences, or related field; advanced clinical degree preferred.
• Experience independently managing a high volume of concurrent safety deliverables across multiple studies in a fast-paced environment.
• Working knowledge of HIPAA, ICH, GCP, and regulatory requirements for clinical research.
• Experience with cardiovascular or structural heart therapeutic areas is a significant advantage.

Responsabilidades

• Independently manage a high-volume, concurrent safety caseload across multiple active clinical studies with overlapping deadlines; prioritize competing demands with minimal oversight.
• Assess adverse events and complaints across multiple studies; perform UADE determinations and report AEs per regulatory requirements.
• Review and analyze aggregate safety reports to identify early safety signals and escalate findings with recommendations.
• Track timeliness of AE/SAE reporting by sites and ensure compliance with timelines.
• Prepare, review, and finalize event narratives and safety data packages for regulatory submissions.
• Own safety sections of IDE Annual Progress Reports and other major submissions end-to-end.
• Build and deliver safety presentations and dashboards for leadership and DSMB/CEC audiences.
• Mentor team members on safety data entry, AE data cleaning, and safety review processes.

Conhecimentos

Cardiology knowledge

MedDRA coding

GCP knowledge

Safety reporting

EDC systems

IDE submissions

Formação

Bachelor's degree in life sciences

Advanced clinical degree (NP/PA/MD) preferred

Ferramentas

MS Office

EDC platforms

Regulatory submissions software

Descrição da vaga

JenaValve Technology, Inc. seeks a Senior Specialist, Clinical Safety to manage high-volume safety activities across ARTIST, ALIGN-AR and JENA-VAD trials, with AE reporting and regulatory submissions, while mentoring peers.

The candidate should have 5+ years in clinical safety/pharmacovigilance, a life sciences degree, knowledge of GCP/HIPAA, MedDRA coding, and safety data management; cardiovascular experience preferred.