Sr. Drug Safety Specialist - MGI Pharma - Bloomington, MN

Sr. Drug Safety Specialist - MGI Pharma - Bloomington, MN

 

Position Overview

Responsible for the appropriate and thorough reporting of adverse experiences from commercial and clinical use of MGI drugs to regulatory authorities

 

Critical Performance Areas

1.  Timely and accurate AE processing

2.  Timely and accurate SAE processing

3.  Timely submission of periodic / annual reports / international responsibilities

4.  Current knowledge of regulatory guidelines

 

Essential Job Functions

? Process adverse events according to established SOPs, FDA and ICH regulations and guidelines

? Evaluate data entry of AE / SAE?s in Oracle AERS and complete assessment of case

? Evaluate and code adverse events using the MedDRA dictionary

? Assist in validation of Oracle AERS database as required

? Provide ad hoc adverse event reports for internal use, reporting to regulatory agencies and answering partner queries

? Interact with Regulatory Affairs to ensure appropriate reporting of post marketing and clinical trial safety reports

? Interact with international partners to provide or obtain appropriate adverse event reports

? Conduct literature searches for safety reports on MGI post-marketed products

? Review materials to ensure consistency and accuracy with clinical data

? Participate on MedDRA coding team

? Provide training to Territory Managers on the reporting of adverse experiences

? Provide material and/or presentations to Sales and Marketing for periodic sales meetings

? Participate in the handling of medical communications calls

? Develop/modify SOPs and guidelines for reporting of adverse experiences

 

Requirements

 

? 4 year college degree in pharmacy, nursing

? 3+ years work experience in basic pharmaceutical research, clinical research or equivalent

? Experience in adverse event reporting

? Proficiency in PC applications

? Integrity

? Current understanding and application of FDA/ICH adverse event reporting requirements

? Excellent communication (written and verbal) skills

 

Other Skills/Abilities

? Advance degree in pharmacy, nursing or related science field preferred

? Oncology and Drug Safety experience desired

? MedDRA experience desired

 

 

NOTE:  This job description is not intended to be all-inclusive. Associate may perform other related duties to meet the ongoing needs of the organization.

 

 

 

 

 AN EQUAL OPPORTUNITY EMPLOYER