[Hiring] Senior Physician, Patient Safety @Parexel

Role Description

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
• 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.

Qualifications

• 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

Requirements

• 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

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