Clinical Drug Safety

• Management of adverse event 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
• Preparation of BLA/NDA and IND safety reports and 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

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

*Job responsibilities and skills required will vary across hiring organizations