The Clinical Safety Reviewer (CSR) participates in the implementation and management of high quality clinical research trials or data registries to ensure safety and effectiveness of Abiomed products.

Job Responsibilities:

• Responsible for tracking and triaging site-reported adverse events (AEs), monitoring timelines for event processing and adjudication by the Clinical Events Committee (CEC) and reviewing summary safety data at regular intervals by Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC) or Independent Medical Monitors (IMM).
• Verifies and reviews site-reported adverse events and serious adverse events to confirm accurate data reporting in accordance with the protocol and the guidelines.
• Reviews patient source documentation, prepares patient narratives for independent adjudication and assists in the presentation of cases for adjudication by the Clinical Events Committee (CEC).
• Recognizes missing/incorrect data and initiates missing data queries/data clarification queries to clinical sites regarding adverse events.
• Requests appropriate source documentation to analyze adverse event for seriousness and causality.
• Schedules regular CEC meetings, prepares and disseminates the materials to the CEC members before meetings.
• Receives the adjudication results from the CEC members, and maintains tracking and documentation  of the adjudicated cases per work instructions or SOPs including CEC meeting minutes and entering adverse event data into safety databases.
• Participates in or is responsible for reconciliation of device safety databases and clinical study databases for adverse event reporting and tally. This includes evaluating clinical database for non-site reported adverse events and their follow-up.
• Interfaces with project management, functional team members, site coordinators and investigators to ensure a timely and precise safety reporting process.
• Reviews and maintains study and regulatory documents.
• Assists with the development of study documents (Protocols, CRFs, ICFs, Charters, Guidelines) or regulatory submissions.
• Attends investigator and coordinator meetings representing the Safety functional group.
• May provide training to site personnel and study team.
• Participates in the execution of the company’s publication plan.
• Assists with the preparation of manuscripts, abstracts, posters and slide presentations on Abiomed products and clinical research initiatives in partnerships with external investigators and medical affairs staff.
• Other responsibilities as assigned.

Job Qualification:

The candidate will have an MD or RN degree and a medical/hospital background.

Needs to be able to read and extract medical information from patient charts and clearly summarize the details according to the clinical study guidelines.

Ability to analyze information and perform clinical triage relating to information synthesized from case report forms and other sources.

Understanding of clinical trials protocols and industry study endpoints and definitions strongly preferred.

Working knowledge of guidelines, systems for clinical trial management and of ICH and GCP regulations and practices.

Prior publications and medical writing experience preferred.

Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs is extremely helpful.

Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.

Ability to multi-task, work on multiple protocols, and interface with team members who are working under deadlines.

Ability to set priorities and excellent planning, project management and time management skills.

Attention to detail and strong organizational skills.

Must be able to travel up to 10% overnight.