Clinical Drug Safety Jobs

• Manage adverse event processing and reporting
• Document correspondence and follow-up
• Maintain AE/SAE records/files and safety database and reconcile with clinical database
• Develop risk management plans and safety reporting criteria for protocols
• Prepare BLA/NDA, IND safety reports, PSURs, investigator communications and product labeling/package inserts

Skills:

• Health professional degree such as RN, BSN, MSN, PA, NP, RPh, PharmD or MD
• Thorough knowledge of FDA and EMEA regulations, ICH/cGMPs/cGCPs and drug safety guidelines
• Adverse event software (e.g., ARISg) and coding dictionaries (e.g., MedDRA) experience
• Medical writing skills

View some of our most recent clinical drug safety jobs below.  To refine your search, use the box to the left to modify the keywords or location.

You can also contact a Kforce team member at mlee@kforce.com or call us at 1-877-4KFORCE.

*Job responsibilities and skills required will vary across hiring organizations