Pharmacovigilance Scientist

Responsible for the receipt and data entry of adverse event reports

following company standard operating procedures, internal business practices

and regulatory guidance documents, to ensure compliance with worldwide

safety regulations and corporate policies.

Activities Include:

*May Triage and classify ICSRs for report type, seriousness, causality,

expectedness/labeling and reporting; prioritize ICSR according to regulatory

requirements

*Confirmation of Safety Coordinator case registry data

*Database searches as necessary

*Completion of remaining case data entry, including narrative or

auto-narrative

*Completion of risk and quality (label, approval, manual coding and quality

review steps).

*Clarification of unclear or illegible information from the LSO or Call Centre

*Discussion of source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician

*Request deletions as necessary

*Single case unblinding

EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill

and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.

*Registered Nurse OR

*Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR

*Licensed Practical Nurse without Bachelors degree but with knowledge of

Drug Safety usually exhibited by minimum 5 years experience in pharmaceutical safety-related role.

Please Contact Me @ 732-429-1635