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Job description
Global Patient Safety
With oversight from GPS TAH, responsible for all Global Patient Safety activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc); review and contribute to clinical documents (Investigator Brochures, protocols, clinical study reports, etc) focusing input on safety sections
Lead cross-function Safety Monitoring Team activities for assigned compounds
Represent Global Patient Safety for assigned compounds on cross-functional teams, including but not limited to “xxx” Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to “XXX”
Proactively identify and develop plans/ strategies for non-compound specific Global Patient Safety activities
Resource for medical review of assigned compounds
Actively participate in the development and maintenance of relevant SOPs and working practices
Actively participates in continuous improvement activities within both the TA and the GPS organization
Requirements
MD required
More than 5 years total relevant experience in PV and/or relevant medical field or equivalent (industry experience in drug safety including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).
Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
Function as a subject matter expert internal and external to PVRM for assigned
Ability to utilize PVRM safety database for purposes of medical case review and simple
Ability to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry.
No. of Vacancies
1
Job Nature
Full-time
Experience Requirements
5
Job Location
New York, US
Job Level
Sr. Position
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Worksite address
new york, NY, 10261, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.