Senior Physician, Patient Safety

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Physician, Patient Safety based in India.** The Senior Physician, Patient Safety will provide medical expertise and oversight across pharmacovigilance activities for investigational and marketed products, helping protect patients throughout the product lifecycle. You will evaluate adverse event reports, assess safety signals, and contribute to benefit-risk assessments to support informed medical and regulatory decisions. Working closely with pharmacovigilance teams, clients, and cross-functional stakeholders, you will help ensure safety information is accurate, consistent, and compliant with international requirements. The role includes reviewing and authoring safety documentation, supporting regulatory submissions, and contributing to risk management strategies. You will also provide medical guidance to colleagues, support audits and inspection readiness, and help improve operational processes. This remote opportunity offers the chance to apply your clinical expertise across diverse therapeutic programs while contributing to patient safety and the development of innovative therapies. ### Accountabilities - Conduct medical review and assessment of individual case safety reports involving adverse events and adverse reactions associated with investigational and marketed products. - Evaluate case causality, seriousness, and expectedness, providing medical guidance to case processing teams and pharmacovigilance specialists. - Perform signal detection, analysis, evaluation, and ongoing safety surveillance, including tracking potential signals and communicating findings to relevant stakeholders. - Review, prepare, and contribute to aggregate safety reports and regulatory documents, including PSURs, PBRERs, PADERS, Risk Management Plans, Benefit-Risk Assessments, Safety Evaluation Reports, Clinical Overviews, Clinical Expert Statements, and Investigator Notification Letters. - Provide medical input on clinical study report narratives, clinical protocols, Investigator Brochures, and other safety-related regulatory submissions. - Conduct literature reviews to support product safety evaluations and the investigation of potential safety concerns. - Maintain up-to-date knowledge of assigned product safety profiles, labeling documents, client procedures, data handling conventions, and global pharmacovigilance regulations. - Collaborate with clients, project managers, patient safety associates, pharmacovigilance operations teams, and other stakeholders to resolve medical review issues and support timely, high-quality deliverables. - Support risk management activities, periodic safety reporting, regulatory compliance, and the ongoing assessment of product benefit-risk profiles. - Contribute to audit and inspection readiness, process improvement initiatives, and operational performance objectives. - Participate in client and cross-functional meetings, providing medical expertise and safety-related recommendations as required. - Train and mentor colleagues, share pharmacovigilance expertise, and act as a subject matter expert when needed. ## Requirements: - Medical degree at the graduate or postgraduate level. - Relevant professional experience in pharmacovigilance, patient safety, clinical research, or a related regulated healthcare environment. - Strong understanding of international patient safety regulations and guidelines, including Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP). - Ability to interpret clinical data, assess medical relevance, and apply sound clinical judgment to safety assessments. - Strong knowledge of adverse event case review, pharmacovigilance processes, and patient safety principles. - Excellent written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams and maintain productive client relationships. - Proficiency with computers, Windows operating systems, web-based applications, and safety-related systems and workflows. - Strong organizational skills and attention to detail, with the ability to manage multiple priorities while maintaining quality and meeting deadlines. - Ability to work effectively in a matrix environment and contribute independently while collaborating with global stakeholders. - Preferred: At least two years of experience in individual case safety report (ICSR) medical review, safety surveillance, signal detection, or signal management. - Preferred: Experience preparing or reviewing aggregate safety reports and regulatory submission documentation, supporting risk management planning and benefit-risk assessments, or working with investigational and marketed products in a global regulatory environment. - Preferred: Experience training and mentoring colleagues or serving as a pharmacovigilance subject matter expert. ## Benefits: - Remote working arrangement within India. - Opportunity to contribute to patient safety and the development of innovative therapies. - Exposure to diverse therapeutic programs and global pharmacovigilance activities. - Opportunities to collaborate with multidisciplinary medical, clinical, regulatory, and safety professionals. - Opportunities to apply and expand medical expertise in safety surveillance, signal management, and risk assessment.