Remote Patient Safety Job at Parexel
A rare chance has emerged for qualified medical professionals through the Parexel Patient Safety Job, as Parexel seeks a Senior Physician, Patient Safety to join their team in a remote capacity. This role offers an opportunity to contribute to patient safety and regulatory compliance while working with global stakeholders.
About Parexel:
Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With over 22,000 employees worldwide, Parexel partners 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. The organization works with focus, agility, and shared purpose to address patient needs and accelerate the delivery of new therapies, embracing bold thinking and adapting quickly to change.
Job Details:
- Position: Senior Physician, Patient Safety
- Location: Remote
Job Description:
In the Parexel Patient Safety Job, the Senior Physician will provide medical expertise and oversight across pharmacovigilance and patient safety activities supporting investigational and marketed products. This role plays a critical part in protecting patient safety, supporting regulatory compliance, and contributing to ongoing evaluation of product benefit-risk profiles throughout the product lifecycle.
Key Responsibilities:
- 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.
Eligibility Criteria:
- Graduation or Post Graduation in Medicine.
- Relevant experience in pharmacovigilance, patient safety, or a related field.
- Strong knowledge of international patient safety regulations, including GCP and GVP.
- Ability to assess the clinical relevance of medical data and interpret its clinical significance.
- Excellent interpersonal, verbal, and written communication skills.
- Computer proficiency, experience with web-based applications, and familiarity with Windows operating systems.
- Ability to manage multiple priorities while maintaining quality and attention to detail.
- Ability to work effectively in a matrix environment and collaborate as part of a team.
Required Skills:
- Strengths in medical assessment, pharmacovigilance, signal detection, and clinical data interpretation.
- Experience working in patient safety, pharmacovigilance, clinical research, or a regulated healthcare environment.
- The ability to collaborate effectively across cross-functional teams while building productive client relationships.
- A patient-focused mindset with strong attention to detail and sound medical judgment.
- Comfort working with safety databases, web-based applications, regulatory requirements, and pharmacovigilance processes.
Preferred Qualifications:
- 2+ years of experience in ICSR medical review or safety surveillance or signal detection and signal management activities.
- Experience preparing, reviewing, or contributing to aggregate safety reports and regulatory submission documentation.
- Experience supporting risk management planning and benefit-risk assessments.
- Experience training, mentoring, or serving as a subject matter expert within pharmacovigilance operations.
- Experience working with investigational and marketed products in a global regulatory environment.
This remote Parexel Patient Safety Job offers qualified candidates an opportunity to make a significant impact on patient safety and the advancement of innovative therapies. Interested individuals are encouraged to apply at the earliest opportunity.
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