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Drug safety scientist skills for your resume and career
15 drug safety scientist skills for your resume and career
1. Chemistry
Chemistry is the branch of science that tells us about the composition, properties, and structure of elements and compounds. The processes these elements undergo and how they undergo change all come under the branch of chemistry.
- Collaborated with external medicinal chemistry consultants to determine and track SAR of compounds.
- Represented toxicology and drug safety on CNS drug development team with chemistry, biology and toxicokinetic counterparts.
2. Drug Discovery
Drug Discovery, in the scientific fields of medicine and pharmacology, refers to the exploration and discovery of new and effective medicinal substances and compounds, most usually through years of dedicated research and a large number of studies, conducted tests, and revisions.
- Implement enterprise-scale compound registration and inventory database supporting drug discovery laboratories.
- Design, deploy, and support web-based registration tools for senior scientists and drug discovery leadership team.
3. Drug Safety
- Reported and provided drug safety documents to appropriate client or FDA for regulatory submission for advisory committee review.
- Authored toxicology drug safety reports and contributed to toxicology and drug safety sections of regulatory documents.
4. Safety Data
Safety data is a document that lists information related to occupational safety and health for the use of substances or products.
- Maintained, reviewed and reconciled safety database and clinical database and evaluated safety trends and risk assessment.
- Conducted aggregate safety analyses on safety data for post-marketing surveillance.
5. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Assisted Study Directors in generation and compilation of study reports and responses to Quality Assurance or FDA audits.
- Communicated with PCPC, CTFA, Health Canada, FDA, etc about safety and regulatory issues.
6. Drug Metabolism
- Assisted in training other Drug Metabolism associate scientists in appropriate bioanalytical techniques and sample preparations.
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- Aided in creation of training program on Safety Signal Detection; supported development of peer-reviewed publication addressing implementation/results of program.
- Involved in the User Acceptance Testing (UAT) of the signal detection system.
9. Data Entry
Data entry means entering data into a company's system with the help of a keyboard. A person responsible for entering data may also be asked to verify the authenticity of the data being entered. A person doing data entry must pay great attention to tiny details.
- Assessed what makes a case reportable to regulatory authority and how the case data entry is structured.
- Contract Position) Performed data entry into USPV using ARGUS Database, along with entry Rules and Guidelines.
10. Drug Candidates
- Developed and established several protocols for performing primary and secondary cell-based assays to screen novel drug candidates.
- Experience with API LC/MS/MS as well as robotic liquid handlers to quantify drug candidates and their metabolites in biological matrices.
11. Immunology
Immunology is a branch of medical service that deals with studying the immune system of a person. This particular specialization focuses on the function of the immune system and how it affects the entire body. It is usually an activity where it develops a mechanism that helps prevent and susceptibility of bacteria, infection, and other viruses that can enter the body.
- Research Field: Preclinical Oncology and Cancer Immunology.
12. Risk Management
Risk management is the method of recognizing, evaluating, and managing risks to an organization's resources and profits. Financial insecurity, regulatory liability, strategic management mistakes, incidents, and natural hazards are just some of the challenges or dangers that could arise. For digitalized businesses, IT security vulnerabilities and data-related threats, as well as risk management techniques to mitigate them, have become top priorities.
- Trained new employees within global pharmacovigilance and risk management on signaling investigations and report writing.
13. LC/MS
- Performed metabolite identification using LC/UV and radioactivity detector and quantitation using LC/MS.
14. MedDRA
- Use of the Argus database and Consumer Response System (CRS) database and MedDRA coding dictionary.
- Performed coding by the use of MedDRA.
15. Product Safety
- Provided comprehensive scientific support to product safety physicians.
- Assisted in special projects within the Product Safety Department to include a QC process to track error metrics.
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Mr. Brian Zimmerman III
Assistant Vice President of Strategic Communications, Earlham College
What type of skills will young drug safety scientists need?
Associate Professor of Science, Assistant Dean, Graduate Programs, Tiffin University
List of drug safety scientist skills to add to your resume

The most important skills for a drug safety scientist resume and required skills for a drug safety scientist to have include:
- Chemistry
- Drug Discovery
- Drug Safety
- Safety Data
- FDA
- Drug Metabolism
- Regulatory Authorities
- Signal Detection
- Data Entry
- Drug Candidates
- Immunology
- Risk Management
- LC/MS
- MedDRA
- Product Safety
- Argus
- Safety Issues
- Regulatory Agencies
- Extraction
- SAR
- Bioanalytical Methods
- Clinical Studies
- Method Development
- GLP
- CRO
- PSUR
- ADME
- QC
- Literature Searches
- R
- Enzymes
- ICH
- Liquid Chromatography
- Arisg
- Evaluation Reports
- Metabolites
- Sample Analysis
- Investigator Brochures
- Peptides
- HTS
- Cell-Based Assays
- AES
- HPLC
- Medical Review
- Medical Assessment
- Metabolism Studies
- Elisa
Updated January 8, 2025