Performs the medical assessment activities related to drug safety Pharmacovigilance for the assigned therapeutic area(s).
The PSSR Medical Reviewer 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.
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.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness /listedness/labeledness, causality, and data reconciliation.
As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.
Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements.
Provide timely input into product related milestones.
Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.
Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.
Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process.
Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues.
Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
Proactively communicate with and engage Therapeutic Area colleagues and key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.
Engage internal and external customers with a sense of urgency and an appreciation of their needs and point of view.
As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with PSSR and/or strategic objectives.
Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio.
Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.
Utilize the corporate performance management process to manage goal setting and individual development. Consistently demonstrate Values and Leader Behaviors.
Proactively mentor Therapeutic Area colleagues to foster an environment of trust, understanding, learning, and development.
Contribute to the mentoring and on-boarding of new PSSR colleagues
Medical Degree from an accredited institution
Minimum of two years of experience as an MD or MBBS in clinical practice
Minimum of two years of relevant experience in Pharmacovigilance , clinical research or related field
Pharmaceutical industry experience preferred
Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports
Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook
Ability to achieve personal objectives while meeting departmental standards of performance
Fluency in oral and written English; knowledge of additional language(s) an advantage
Experience and skill with medical writing an advantage