1997 Tipple Road
Line Lexington, PA 18932
Job Objective To obtain a Drug Safety Physician position that will allow me to utilize my skills and has potential for growth.
Highlights of Qualifications:
- Hands-on experience in drug safety research, evaluation and documentation activities
- Immense knowledge of pharmaceutical medicine, drug development process, pharmacovigilance and drug safety principles
- Operational knowledge of using EDC MediData, Safety Database ARISg, and MS Office Suite
- Familiarity with various domestic and international Regulatory Health Authorities
- to create and implement Risk Management Plans for drugs
- Ability to interpret and follow international Drug Safety reporting regulations and guidelines
Drug Safety Physician
PAREXEL International, Line Lexington, PA
August 2012 – Present
- Analyzed and comprehended complex safety data related to metabolic drugs.
- Oversaw and assisted in designated clinical studies of pharmaceuticals.
- Advised and supervised Drug Safety Associates and Specialists in medical aspects of drug related studies.
- Developed and maintained positive relationships with medical staff, research department and regulatory agencies.
- Composed andprovided in-depth and accurate drug safety reports to the regulatory agencies.
- Interpreted and followed internal and applicable global regulatory regulations.
Drug Safety Physician
Upsher-Smith Laboratories, Line Lexington, PA
May 2009 – July 2012
- Supported and conducted pharmacovigilance activities on individual and group of pharmaceutical drugs.
- Evaluated and interpreted all clinical trial data and drug-safety information.
- Documented and reported drug-related trial resultsand reports to appropriate team.
- Served on Risk Management Committees and participated in risk management activities.
- Discussed and liaised with assigned team and partners to resolve safety issues and improve work processes.
- Interpreted and complied withnational and international regulations related to processing and reporting of safety data.
Doctor of Medicine
University of Texas Medical Branch at Galveston, Galveston, TX
- 1File Count
- March 1, 2020Create Date
- March 1, 2020Last Updated