Risk Management, Lead
|Contact Name:||Director of The RFT Group|
Our client is a young exciting science-based multinational biopharmaceutical company. Known for its scientific and operational excellence, our client is enjoying exceptional growth driven by outstanding performance by its commercialised products combined with a very strong high potential pipeline. Rapid expansion has led to the need to create a management position in Risk Management to be based in their Dublin office
Responsible for RM Lead activities for numerous and complex compounds. Take initiative / assume lead role in across-compound RM activities. Serve as in-house expert on designated RM topics. May assume personnel management responsibilities.
With oversight from Head of RM, responsible for all risk management 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 Risk Management for assigned compounds on cross-functional teams, including Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to
Proactively identify and develop plans/ strategies for non-compound specific risk management activities
Resource for medical review of assigned compounds
Actively participate in the development and maintenance of relevant SOPs and working practices
Actively participate in process improvement activities within PVRM
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 required.
Function as a subject matter expert internal and external to PVRM for assigned compounds.
Ability to utilize PVRM safety database for purposes of medical case review and simple queries.
Ability to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
M.D. / pharmaceutical physician preferred
Clinical experience and 2+ years of 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).
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