Senior Physician, Patient Safety

This is a fully remote position, open to applicants in India.

📋 Description

• Deliver medical review, analysis, and guidance throughout the lifecycle of adverse event and adverse reaction case handling and reporting.

• Execute signal detection, analysis, evaluation, and continuous safety surveillance.

• Offer medical guidance to Patient Safety Associates and pharmacovigilance specialists.

• Review and provide medical input for Clinical Study Report narratives.

• Review and support PSURs, PBRERs, PADERS, Risk Management Plans, Benefit-Risk Assessments, Safety Evaluation Reports, Clinical Overviews, Clinical Expert Statements, and Investigator Notification Letters.

• Keep up-to-date with product safety profiles, labeling documents, client procedures, data handling conventions, and international patient safety regulations.

• Assist in ensuring compliance with global regulatory requirements, reporting obligations, and timelines.

• Collaborate with project managers, clients, and internal stakeholders to address safety-related issues.

• Participate in client and cross-functional meetings as a patient safety expert.

• Aid in inspection readiness, audits, process improvements, and operational performance goals.

• Conduct medical review of individual case safety reports and evaluate causality, seriousness, and expectedness.

• Review and author aggregate safety reports.

• Perform literature reviews for product safety evaluation.

• Contribute to pharmacovigilance and risk management initiatives.

• Assist in developing and reviewing safety content for clinical protocols, study reports, Investigator Brochures, and regulatory submissions.

• Execute signal management activities, including data analysis, assessment, tracking, presentation, and stakeholder collaboration.

• Train and mentor team members while serving as a subject matter expert.

⛳️ Requirements

• Bachelor's or Master's degree in Medicine.

• Relevant experience in pharmacovigilance, patient safety, or a related field.

• Strong understanding of international patient safety regulations, including GCP and GVP.

• Ability to assess the clinical relevance of medical data and interpret its clinical significance.

• Exceptional interpersonal, verbal, and written communication skills.

• Proficiency in computer systems, experience with web-based applications, and familiarity with Windows operating systems.

• Capability to manage multiple priorities while ensuring quality and attention to detail.

• Ability to work effectively in a matrix environment and collaborate as part of a team.

• Preferred: 2+ years of experience in ICSR Medical review, safety surveillance, signal detection, or signal management activities.

• Experience in preparing, reviewing, or contributing to aggregate safety reports and regulatory submission documentation.

• Experience in supporting risk management planning and benefit-risk assessments.

• Experience in training, mentoring, or acting as a subject matter expert within pharmacovigilance operations.

• Experience working with investigational and marketed products in a global regulatory environment.

🏝️ Benefits

• Remote work arrangement.

• Full-time employment.