About Parexel:
Parexel is a leading global clinical development partner delivering insight driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.
About the Role:
We are seeking a Senior Physician, Patient Safety to join our team in a Remote capacity. As a Senior Physician, Patient Safety you will provide medical expertise and oversight across pharmacovigilance and patient safety activities supporting investigation and marketed products. This role plays a critical part in protecting patient safety, supporting regulatory compliance, and contributing to the ongoing evaluation of product benefit risk profiles throughout the product lifecycle.
You will provide medical review, analysis, and guidance throughout the adverse event and adverse reaction case handling and reporting process. In addition, you will contribute to signal detection, safety surveillance, aggregate reporting, risk management activities, and regulatory submissions while partnering with clients, patient Safety Associates, pharmacovigilance operations teams, and other stakeholders. Responsibilities include medical review of safety cases, safety report review and authoring, signal management, risk assessment activities, and provision of expert medical guidance to support high quality safety outcomes.
You will join a collaborative, growth focused environment where your clinical expertise directly contributes to patient safety and the advancement of innovative therapies. This role offers the opportunity to work across diverse therapeutic programs, engage with global stakeholders, and make a meaningful impact on clinical research and drug development.
Key Responsibilities:
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Provide medical review, analysis, and guidance throughout the case handling and reporting lifecycle for adverse events and adverse reaction reports associated with investigational and marketed products.
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Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities.
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Provide medical guidance and support to patient Safety Associates and pharmacovigilance specialists on patient safety related matters.
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Review and provide medical input for narratives prepared for Clinical Study Reports.
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Provide medical review and support for safety reports including PSURs, PBRERs, PADERS, Risk Management Plans, Benefit Risk Assessments, Safety Evaluation Reports, Clinical Overviews, Clinical Expert Statements, and Investigator Notification Letters.
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Maintain knowledge of assigned product safety profiles, labeling documents, client procedures, data handling conventions, and international patient safety regulations.
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Ensure awareness of global regulatory requirements and reporting obligations to support compliance with internal and regulatory timelines.
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Collaborate with project managers, clients, and internal stakeholders to resolve review and safety related issues.
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Participate in client and cross functional meetings and provide safety expertise as required.
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Support inspection readiness activities, audits, process improvements, and achievement of operational performance objectives.
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Perform medical review of individual case safety reports, assess causality, seriousness, and expectedness, and provide medical advice to case processing teams.
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Review and author aggregate safety reports for medical accuracy, context, and consistency.
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Conduct literature reviews for product safety assessment and evaluation of potential safety issues.
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Contribute to pharmacovigilance and risk management activities through safety surveillance strategies, risk management plans, and periodic safety reporting.
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Support safety content development and review for clinical protocols, study reports, Investigator Brochures, and regulatory submissions.
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Perform signal detection and signal management activities, including data analysis, signal assessment, tracking, presentation, and collaboration with key safety stakeholders.
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Train and mentor team members and serve as a subject matter expert when required.
You’ll thrive in this role if you bring:
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Strengths in medical assessment, pharmacovigilance, signal detection, and clinical data interpretation.
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Experience working in patient safety, pharmacovigilance, clinical research, or a regulated healthcare environment.
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The ability to collaborate effectively across cross functional teams while building productive client relationships.
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A patient focused mindset with strong attention to detail and sound medical judgment.
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Comfort working with safety databases, web-based applications, regulatory requirements, and pharmacovigilance processes.
Required Qualifications:
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Graduation or Post Graduation in Medicine.
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Relevant experience in pharmacovigilance, patient safety, or a related field.
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Strong knowledge of international patient safety regulations, including GCP and GVP.
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Ability to assess the clinical relevance of medical data and interpret its clinical significance.
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Excellent interpersonal, verbal, and written communication skills.
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Computer proficiency, experience with web-based applications, and familiarity with Windows operating systems.
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Ability to manage multiple priorities while maintaining quality and attention to detail.
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Ability to work effectively in a matrix environment and collaborate as part of a team.
Preferred Qualifications:
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2+ years of experience in ICSR Medical review or safety surveillance or signal detection and signal management activities.
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Experience preparing, reviewing, or contributing to aggregate safety reports and regulatory submission documentation.
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Experience supporting risk management planning and benefit risk assessments.
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Experience training, mentoring, or serving as a subject matter expert within pharmacovigilance operations.
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Experience working with investigational and marketed products in a global regulatory environment.
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