Senior Physician, Patient Safety

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.

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.

• 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.

• Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities.

• Provide medical guidance and support to patient Safety Associates and pharmacovigilance specialists on patient safety related matters.

• Review and provide medical input for narratives prepared for Clinical Study Reports.

• 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.

• Maintain knowledge of assigned product safety profiles, labeling documents, client procedures, data handling conventions, and international patient safety regulations.

• Ensure awareness of global regulatory requirements and reporting obligations to support compliance with internal and regulatory timelines.

• Collaborate with project managers, clients, and internal stakeholders to resolve review and safety related issues.

• Participate in client and cross functional meetings and provide safety expertise as required.

• Support inspection readiness activities, audits, process improvements, and achievement of operational performance objectives.

• Perform medical review of individual case safety reports, assess causality, seriousness, and…