Senior Physician, Patient Safety

🕒 June 12

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 51%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Provide medical review, analysis, and guidance throughout the adverse event and adverse reaction case handling and reporting lifecycle • Conduct signal detection, analysis, evaluation, and ongoing safety surveillance activities • Provide medical guidance and support 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 • Maintain knowledge of product safety profiles, labeling documents, client procedures, data handling conventions, and international patient safety regulations • Ensure compliance with global regulatory requirements, reporting obligations, and timelines • Collaborate with project managers, clients, and internal stakeholders to resolve safety-related issues • Participate in client and cross-functional meetings and provide safety expertise • Support inspection readiness, audits, process improvements, and operational performance objectives • Perform medical review of individual case safety reports and assess causality, seriousness, and expectedness • Review and author aggregate safety reports • Conduct literature reviews for product safety assessment • Contribute to pharmacovigilance and risk management activities • Support safety content development and review for clinical protocols, study reports, Investigator Brochures, and regulatory submissions • Perform signal management activities including data analysis, assessment, tracking, and presentation • Train and mentor team members and serve as a subject matter expert

🎯 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 • Experience working in patient safety, pharmacovigilance, clinical research, or a regulated healthcare environment • 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

🏖️ Benefits

• Remote capacity • Collaborative, growth focused environment • Opportunity to work across diverse therapeutic programs • Engagement with global stakeholders • Training and mentoring opportunities