Medical Reviewer

RESPONSIBILITIES:

- Conduct review and assessment of serious spontaneous reports of adverse events and perform causality assessment of clinical trials and solicited reports.
- Determine regulatory reportability 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 as appropriate.
- Conduct assessment of litigation cases across products/sites as assigned.
- Review and provide assurance of medical content and clinical relevance of regulatory safety documents including Investigators' Brochures, PSURs and ad hoc regulatory reports as assigned.
- In collaboration with the Medical Director, assist in pharmacovigilance activities through active follow-up of cases to obtain additional information as assigned.
- Identify and resolve case issues, coordinate with therapeutic teams/site for specific products or functional groups as appropriate.
- Communicate and interact effectively within and across Therapeutic Teams, and within Functional Team Management as appropriate.
- Acquire and maintain knowledge of applicable Global Health Authority regulations.

SKILLS

ONLY Doctor of Medicine candidates will be considered.
Good medical knowledge; sound medical judgement; good communication skills required; must be able to prioritize/good organizational skills.
Intermediate MS Word desired.

Synectics is an Equal Opportunity Employer.