Description
DESCRIPTIONThe Medical Reviewer will conduct review and assessment of serious spontaneous reports of adverse events and perform causality assessment of clinical trials and solicited reports.
Responsibilities
- Determine regulatory report ability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team, and across all products/sites, as necessary, and in a timely fashion
- Perform triage on cases and determine seriousness and relatedness across products/sites as assigned
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic teams as appropriate
- Escalate complex case issues on team product(s) to the Medical Director of the therapeutic team
- Conduct assessment of litigation cases across products/sites
- Review and provide assurance of medical content and clinical relevance of regulatory safety documents including Investigators, Brochures, and ad hoc regulatory reports
- In collaboration with the Medical Director, assist in pharmacovigilance activities through active follow-up of cases to obtain additional information
- Identify and resolve case issues, coordinate with therapeutic teams/site for specific products, or functional groups
- Communicate and interact effectively within and across therapeutic teams, and within Functional Team Management
- Acquire and maintain knowledge of applicable Global Health Authority regulations.
- MD required with 2 - 4 years relevant experience (clinical or drug safety).
- Good communication skills
- Able to prioritize/good organizational skills
- Have only one (1) year of tenure remaining.
SKILLS
Medical Doctor (MD)
Synectics offers competitive salaries and a full suite of benefits. EOE.