Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Safety Medical Review Physician.
Major tasks and responsibilities will include :
Responsible for the medical evaluation of cases from spontaneous reports, clinical trials, and post marketing surveillance source.
Ensures compliance with relevant regulations and internal SOPs.
Determines seriousness, listedness, and causality.
Summarizes company position for single case reports.
Timely initiation and support of analyses of similar events for SUSAR reporting.
Ensures correct coding of all event and drug terms.
Ensures inter- and intra-consistency for case evaluations.
Provides medical guidance for case follow up.
Participates in ICSR reporting compliance analysis and respective CAPA.
Serves as mentor to Medical Evaluators and Case Managers.
Participate in SETs and SMTs and provide guidance on SAE handling to ensure compliance with relevant regulations, internal SOPs and WINs.
Collaborates with the Risk Management function to review and provide input in study protocols and Investigator Brochures (IBs).
Provides detailed proposals concerning process improvement and optimization.
We seek candidates with the following qualifications :
Medical degree required.
Must have a minimum of 2+ years of pharmaceutical industry experience in Drug Safety and Pharmacovigilance.
Requires a minimum of 2+ years of clinical experience.
If interested, please email your resume as a Word attachment to us, reference 3885. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.