392 Ocean Ave
Peoria, AZ 85382
Job Objective To obtain a Drug Safety Associate position that will promote growth, stability and opportunity for advancement.
Vast clinical experience in reporting post-marketing events in the pharmaceutical industry
In-depth knowledge of US and ICH safety reporting regulations and guidelines
Remarkable knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information
Remarkable knowledge of scientific terms and medical terminology
Basic understanding of FDA and international regulations
Proficient in data entry and drug safety database
Excellent written and verbal communication skills
Proven interpersonal, organizational skills and analytical thinking
Drug Safety Associate, August 2005 to till date
Forest Laboratories, Inc., Peoria, AZ
- Established work priorities and directions independently with minimal input from Manager.
- Collected, documents, and processed adverse event (AE) reports from clinical trials and post-marketing sources adhering to Standard Operating Procedures.
- Prepared clinical narrative summaries for ‘Adverse Event’.
- Performed active follow-up via telephone contact with consumers and health care professionals.
- Ensured timely coverage to Regulatory Authorities and pharmacist.
- Participated in preparing safety reports and maintained clinical databases.
Drug Safety Associate, May 2000 to July 2005
OSI Pharmaceuticals, Peoria, AZ
- Identified case assessment related problems and reviewed reports.
- Identified potential product complaints.
- Performed medical coding using MedDRA and WHO-Drug dictionaries and composes case narratives.
- Determined follow-up requirements and recommend follow-up.
- Performed effectively on assigned cases.
Bachelor’s Degree in Pharmacy, Southern Wesleyan University, South Carolina, SC