General Manager at Professional Access Resources Consulting Pvt. Ltd.
Views:516 Applications:31 Rec. Actions:Recruiter Actions:4
Lead Medical Monitor - Clinical Research Firm (2-5 yrs)
Lead Medical Monitor @ Leading Clinical Research Org
- 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.
- 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.
Desired Candidate Profile -
- Medical training including an MD degree, RN degree, or a physician assistant degree, or equivalent
- Exp in clinical trials research with 2-4 years exp in safety/pharmacovigilance preferred
- 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.
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.