NOTE: The title of the job depends on the discretion of the hiring manager.

Global Patient Safety

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

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about “xxx” unwavering commitment to combining good science & good business.