What are the responsibilities and job description for the Tech II Active Ingredient (Cell Lab)/ASEPTIC TECHNIQUE CHANGE CONTROL MANAGEMENT/CLEAN ROOM position at Maxis Clinical Sciences?
Hybrid; Onsite in either Duluth, GA or St. Joseph, MO 3 days per week
Job Description:
Ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc.)as described in the corporate and BIAH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations.
Review, Assess and approve product/adverse event complaints for company products manufactured or sold in the US, and submit to appropriate authorities as required.
May provide support to Pharmacovigilance(PV)Management in the area of ADE analysis, PV trending and/or signal detection.
Skills:
Three(3)Years of veterinary practice experience or Pharmacovigilance, Pharmacoepidemiology or related field experience
Education:
Veterinary degree (DVM or VMD) required from an accredited veterinary college.
