Job Description
Organizational Relationship(s) including to whom the position reports (title):
Reports to Therapeutic Area Head
Position Purpose
The Associate Medical Director / Medical Director (PSSR MD) performs the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The PSSR MD proactively evaluates safety information from individual cases and cumulative data , identifies and analyzes potential signals , and communicates data - driven conclusions to internal and external stakeholders.
Primary Responsibilities
Perform single case medical assessment , including the determination of seriousness , expectedness / listedness / labeledness , and causality of adverse events in compliance with current regulations , internal and external guidance documents , Standard Operating Procedures , Safety Job Aids , the Argus User Reference Guide and case processing / coding conventions.
Maintain the timely submission of expedited reports.
Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria , prepare the SUSAR narrative , perform risk assessment , initiate the unblinding process (as appropriate) , and make the report available for distribution.
Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data - driven decisions and communicate these findings proactively and effectively to the key stakeholders.
Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.
Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.
Reports to Therapeutic Area Head
Position Purpose
The Associate Medical Director / Medical Director (PSSR MD) performs the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The PSSR MD proactively evaluates safety information from individual cases and cumulative data , identifies and analyzes potential signals , and communicates data - driven conclusions to internal and external stakeholders.
Primary Responsibilities
Perform single case medical assessment , including the determination of seriousness , expectedness / listedness / labeledness , and causality of adverse events in compliance with current regulations , internal and external guidance documents , Standard Operating Procedures , Safety Job Aids , the Argus User Reference Guide and case processing / coding conventions.
Maintain the timely submission of expedited reports.
Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria , prepare the SUSAR narrative , perform risk assessment , initiate the unblinding process (as appropriate) , and make the report available for distribution.
Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data - driven decisions and communicate these findings proactively and effectively to the key stakeholders.
Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.
Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.
Company Profile
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functionsunderpinned by the worlds largest delivery networkAccenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 373,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives.
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