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Director, Safety Physician - Remote
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Full-time
Remote
- Prepare Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS), • Lead the determination of Adverse Reactions section of the product label; leads and support the preparation and review of other safety relevant sections of the label.
- Facilitate and ensures communication with departments that may be involved with receiving, investigating, or reporting AEs. • Collaborate with and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives.
- Assist Data Management with MedDRA and WHO dictionary codes and other medical perspective.
- Review of the case information entered in the safety database to ensure quality and accuracy of the data entered (i.e., updates and corrects MedDRA and WHO dictionary codes).
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines) required.
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