SAFETY SCIENTIST

Top 10 Pharmaceutical Company with a location in Hopewell, NJ is seeking a Safety Scientist to join their team.

Description:
Candidate must provide scientific and technical (including medical writing) support to the GPV product safety physicians for all safety reports [individual cases and aggregate reports, including responses to ad hoc queries regarding safety issues; analysis and interpretation of safety issues arising from clinical trials or post-marketing surveillance, preparation of aggregate reports (e.g., periodic safety updates (PSURs), periodic adverse drug experience reports (PADERs), ad hoc reports, and safety sections of package inserts]. Requires an understanding of clinical data management in relation to assessing clinical trial data. Also requires knowledge of computer applications and project planning skills.
REQUIREMENTS
Qualifications:
The successful applicant must have a B.S.N. (R.N.) or P.A. or B.A/B.S./M.S. Life Science or M.T. ASCP or R.Ph. or Pharm.D. Candidate should have familiarity with safety regulatory guidelines/references, how to access them, and when to refer to them; PSUR (periodic safety update report) experience (assemble and write).