Primary Purpose

The Safety Monitor is responsible for coordinating the safety aspects of the project with the medical monitor and the project team.

Responsibilities

- Collaborates with clinical investigators to determine study design.

- Provides safety review and first line evaluation of serious adverse events (SAEs).

- Maintains ongoing database of SAEs.

- Maintains a summary narrative for each reported SAE suitable for inclusion in DSMB reports, regulatory submissions and final study

reports.

- Reconciles SAEs in the database as needed.

- Communicates with Company and/or site staff regarding reported AEs or SAEs to gather additional information.

- Submit applicable documentation to regulatory authorities such as DCGI and Ethics committee regarding adverse events.

- Responds to site and client requests for information regarding safety in clinical trials.

- Reviews and contributes to Data Safety Monitoring Committee/Board reports regarding safety; review and contribute to safety

sections of annual reports, and periodic safety reports.

- Participates in DSMB and other safety review meetings.

- Participates in the planning and preparation of the adverse event section of protocols for studies

- Collaborates with Protocol Monitor to assure site compliance and understanding of all safety reporting requirements.

- Participates in Clinical Team meetings and similar meetings representing Safety Department.

- Provides adverse event and clinical trial expertise to training effort.

- Performs MedDRA coding for Adverse Events.

- Performs WHO drug coding for concomitant medications.

- Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT),

project SOP and Compliance/Variance table development, participation of internal and external audits, and professional

development activities.

- Demonstrates understanding of project and corporate SOPs by producing work in compliance with the

SOPs. Maintains documentation required by corporate and project SOPs.

- Contributes to drafting and review of corporate SOPs related to safety.

Experience :

- Requires medical training including an MD degree, RN degree, or a physician assistant degree, or equivalent.

- Experience in clinical trials research with 2-4 years- experience in safety/pharmacovigilance preferred.

- Excellent knowledge of medical terminology and ability to extract information to create a case history.

- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.

- Thorough knowledge of regional and international regulations pertaining to pre-marketing and post marketing safety and surveillance.

- Working knowledge of MedDRA dictionary with relevance to adverse event analysis and adverse event coding.

- Working knowledge of WHO drug dictionary with relevance to concomitant medication analysis and coding.

- Excellent oral and written communication skills.

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