What are the responsibilities and job description for the Pharmacovigilance Director position at Talent Groups?
- Expert experience in the Argus Safety system and RxLogix PV Reports
- 10- 12 years of relevant experience and Bachelors/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.). Ten plus years of relevant experience in Safety Systems (e.g. Argus, Aris Global, Veeva, reporting tools, etc.) in capacity of maintenance, technical interface, and reporting tools
- Strong technical experience with ability to lead projects and ensure timely successful completion
- Knowledge of other drug safety solutions/ relational databases, SQL preferred
- Solid knowledge of GCP/GVP regulations and guidelines (including FDA, EMA and ICH E2B safety reporting).
- Familiar with Pharmacovigilance Summary Master File (PSMF) document and have ability to contribute towards required audit-related information.
- Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (i.e., eTMF, EDC, Argus, ArisG, IVRS) including electronic gateway for submissions
Salary : $120 - $125