General Manager at Professional Access Resources Consulting Pvt. Ltd.
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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.
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