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Job Description: Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Position Summary / Objective
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.
• Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair. Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
• Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
• Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
• Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
• Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.
Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.
Key Competency Requirements
• Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
• Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
• Ability to work well in cross-functional teams.
• Good collaborative and communication skills with scientific subject matter.
• Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
• Understand aspects and methods for data analysis, interpretation and presentation.
• Possess good working skills in MS Word, Excel and PowerPoint, including statistics
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