Senior Director / Director / Associate Director – DRUG SAFETY...
Alpha Clinical, new york, ny, United States
Overview
NOTE: The title of the job depends on the discretion of the hiring manager.
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
Responsibilities
- 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
Additional Information
- No. of Vacancies: 1
- Job Nature: Full-time
- Experience Requirements: 5
- Job Location: New York, US
- Job Level: Sr. Position