NH - Medical Reviewer
2 - 5 YearsChennai
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Posted: 1 day ago
Job Description
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.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness / listedness / labeledness , causality , and data reconciliation
Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Researcher
Role: Clinical Researcher
Keyskills:
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.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness / listedness / labeledness , causality , and data reconciliation
Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Researcher
Role: Clinical Researcher
Keyskills:
Desired Profile
Medical Degree from an accredited
institutionMinimum of two years of experience as an MD in clinical
practiceMinimum of two years of relevant experience in
pharmacovigilance, clinical research or related field Pharmaceutical
industry experience preferredWorking 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 report
Education:UG -Any Graduate - Any Specialization
PG - Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Education:UG -Any Graduate - Any Specialization
PG - Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
About Accenture
Accenture is a global management consulting, technology services and
outsourcing company, with more than 323,000 people serving clients in
more than 120 countries. Combining unparalleled experience,
comprehensive capabilities across all industries and business functions,
and extensive research on the worlds most successful companies,
Accenture collaborates with clients to help them become high-performance
businesses and governments. The company generated net revenues of
US$30.0 billion for the fiscal year ended Aug. 31, 2014. Its home page
is www.accenture.com.
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