of ethics, HIPPA and Atlanta EMA Case Management Standards to ensure a high level of professionalism is maintained. Address...
required. Experience in post-marketing pharmacovigilance/drug safety. Strong knowledge of: FDA and EMA PV regulations ICH E2...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...
, and compliance metrics to drive decision-making. Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements.... Experience with regulatory inspections and audits (FDA, EMA, or other health authorities). Knowledge & Skills Ability...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...
, EMA, and global clinical regulatory requirements #LI-AB1 U.S. Pay Range $192,600.00 - $260,600.00 The pay range...
regulations (ICH, FDA, EMA, MHRA). Proven track record supporting clinical development, regulatory submissions, and post...
(pharma, biopharma, or biologics manufacturing) Strong working knowledge of GMP regulations (FDA, EMA, ICH) and inspection...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...