Associate Dir. Cross TA Risk Management
Pharmacovigilance Practice (GPvP) is preferred. Health Authority Inspection experience (FDA, EMA, and other inspectorates...
Pharmacovigilance Practice (GPvP) is preferred. Health Authority Inspection experience (FDA, EMA, and other inspectorates...
, certifications, and regulatory agencies (e.g. FDA, Health Canada, EMA, etc.). To include the following tasks: Direct the site...
, including FDA, USDA/CVB, EMA, and other global agencies Drive planning, preparation, and submission of regulatory dossiers...-CVB, FDA-CVM, EMA, and VICH regulatory requirements Experience supporting manufacturing changes, tech transfer, or post...
to providers when necessary. Navigate EMA/EMR systems to process faxes, tasks, chart updates, and documentation. Create new... in EMA. Schedule surgeries and procedures according to provider-specific templates, guidelines, and availability...
., FDA, EMA, WHO, MHRA). Ensure compliance with Good Distribution Practices (GDP) and other applicable quality standards...
in EMA. Ensuring MIPS information is consistently and accurately completed in the medical record. Assisting... (i.e., Medicare, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures...
in EMA. Maintain a clean, organized, and professional reception area and restroom facilities Scheduling & Appointment... requirements. Enter correct payer ID, payer name, and address information into EMA. Update and maintain the PA log, ensuring...
in managing SOPs, change controls, and regulated documentation Experience supporting FDA, EMA, or other regulatory inspections...
, ISO, Anvisa, EMA) and quality systems Experience supporting audits and maintaining audit-ready documentation Deep...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...