South Lyon, Michigan, United States
Ensured safety and regulatory compliance of pharmaceutical products through comprehensive monitoring and evaluation of adverse events (SAEs) in clinical trials and post-marketing settings. Review and analyze clinical trial data, managing timely identification, documentation, and reporting of AEs in accordance with regulatory standards (ICH-GCP, FDA, EMA). Maintained compliance with internal Standard Operating Procedures (SOPs) for pharmacovigilance activities, ensuring adherence to best practices in adverse event reporting and risk management. Collaborated with cross-functional teams to prepare and submit. Periodic Adverse Drug Experience Reports (PADERs) and regulatory safety documents Perform proactive literature monitoring to identify and evaluate potential safety signals. Support regulatory submissions by preparing and reviewing PADERs, ensuring accuracy in data analysis and regulatory compliance. Successfully identified safety signals through comprehensive literature monitoring, leading to early intervention and updates to product safety information.
Chiropractic adjustments: proficient in techniques such as spinal manipulation, extremity adjustments and soft tissue therapy for all age groups. Patient assessment and diagnosis: skilled in conducting patient assessments including physical examination crucial for patient recruitment and data collection in clinical trials. Patient chart review on an ongoing basis with special emphasis on medical history and medication history. Rehabilitation and therapeutic exercise: proficient in designing and implementing rehabilitation programs and therapeutic exercises to aid patient recovery. Pain management: pain management plans using noninvasive techniques. Collaborate with family physicians and physical therapists. Diagnostic imaging; X-ray, MRI, CT, and ultrasound with a proficiency in interpreting complex medical data.
Chiropractic adjustments, spinal manipulation, extremity adjustments most often with pediatric and obstetric patients. Passive and active care along with PT. Nutritional support and advice for patients. Diagnostic imaging: X-ray, MRI, CT, and ultrasound.Clinical reasoning. Focus on record keeping and documentation.
Chiropractic adjustments using strong anatomical, physiological, and biomechanics skill set. Patient education and communication. Documentation of patient records. Effective collaboration with family physicians, massage therapists, physical therapists, and Chinese medicine.