Pharmacovigilance Physician - PVP

ID# DCPA207040

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Requirements/Skills: 

  • Medical degree and Board Certified/Board Eligible or equivalent preferred. Or 2 years post-graduate training or combination of 5 years post-graduate training in a recognized medical specialty plus clinical medical experience acceptable. An unrestricted medical license or equivalent or eligibility in one of the GMS operational regions required. 
  • Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports. 
  • Provide medical and patient safety support to therapeutic team for pre- and post-marketing programs 
  • Performs medical case review of individual case safety reports (ICSRs) and patient narrative, including review of source documentation as needed 
  • Performs medical review of ICSR coding 
  • Review seriousness, expectedness/listedness and causality of each event in the ICSR 
  • Review due diligence queries as needed and raise additional medical queries for pertinent information regarding ICSR 
  • Review watchlist cases as needed 
  • Provide medical support for the Analysis of Similar Events (AOSE)-IND Safety Letters. PVP, in collaboration with the project physician, prepares an Analysis of Similar Events for serious, unlisted, associated adverse events occurring in specified IND clinical trials. 
  • Provide medical guidance and opinions to drug safety associates, other GMS physicians and scientific staff in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested. 
  • Familiarity with pharmaceutical industry principles of drug development and Pharmacovigilance is preferred but not required.

 

Position Details:

Medical Device

Scientific

Start Date: 
9-3-2013
End Date: 
12-31-2013

HORSHAM, PA

CON_W2

37.5

DCPA207040

No

No