Must be able to exercise appropriate judgment, as necessary.
Requires a high level of initiative and independence.
Excellent written and oral communication skills required.
Requires ability to use a personal computer for extended periods of time.
Remote Pharmacovigilance Consultant duties:
Responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (e.g. Commercial) and will be responsible for adverse event handling and reporting and for general PVRM operations, including support of the global PV system.
Responsible for training management, including development and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the CTSA mailbox, and is the PVRM Team Room administrator, including file management, archiving activities, and document retention initiatives.
Contributes to audit and inspection preparedness, and is a member of a cross-functional working team supporting PVRM audits and inspections.
Works closely with the Information Management (IM) and Safety Science groups as part of a matrix team to support PV activities.
Numbers & Facts
Location
Boston, Massachusetts (Remote)
Skills
Adverse Eventsunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Consultingunmatched
Cross-Functionalunmatched
Document Archivingunmatched
File Managementunmatched
Multitaskingunmatched
Operational Supportunmatched
PC (Personal Computer) Systemsunmatched
Pharmacovigilanceunmatched
Presentation/Verbal Skillsunmatched
Quality Managementunmatched
Quality Monitoringunmatched
Writing Skillsunmatched
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