Erwin A

Clinical Pharmacovigilance/Drug Safety


Clinical Pharmacovigilance/Drug Safety

Education Level:

Medical Degree

Will Relocate:



SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs. * Experience in the role of a Medical Safety Officer. * Experience in Medical case and aggregate data evaluation, signal detection, risk assessment and risk minimization, labeling, preparation of periodic safety reports for clinical trials and post-marketing data. * Excellent clinical judgment and ability to communicate and follow up on complex clinical issues in a scientific and understandable manner. * Experience in Safety Operations, planning and managing worldwide product safety surveillance and reporting to the FDA and other World regulatory authorities * Experience on MedDRA, coding and retrieval of preferred terms * Experience with implementation and validation of electronic Safety data bases and user requirements I.E, Argus, (E2B) for electronic submissions, Aris G * Experience in writing and training on Standard Operating Procedures, Business practices, working instructions, training Manuals, and Forms applicable to Pharmacovigilance * Strong interpersonal, Team Management and strong leadership skills * High energy, outstanding work ethics and reputation for integrity * Medical evaluation and assessment of clinical and post-marketing adverse event reports. Experienced with preparation of investigational and post marketing regulatory reports * Proficient with standard desktop computing programs and safety databases * Excellent oral and written communication skills * Demonstrates consistent attention to detail * Highly motivated, organized, and understanding of workflow prioritization * Management and leadership experience * Personnel growth and development * Able to multi-task various projects * Able to work as a contributor or in a team environment.