Senior Physician, Patient Safety
Primary Location: India, Remote Job ID R0000037591 Category Medical SciencesAbout this Role
Senior Physician, Patient Safety performs medical, safety monitoring or pharmacovigilance activities for assigned projects. They provide medical reviews, analysis and guidance in all required safety reports. Senior Physician, Patient Safety will act as Subject Matter Expert in therapeutic areas and mentor junior team members while working on complex tasks requiring in-depth evaluation.
Brand safety Physician
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues
Support the preparation and maintenance of Risk Management Plans
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client, as required.
Writing Marketing Authorization Holder (MAH) comment and assessing company causality.
Review appropriateness of medical content in narrative for medical coherence.
Assessing seriousness, listedness / expectedness of reported events.
Providing medical inputs to case processing team
Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs
Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)
Coordinate safety activities between Drug Safety Unit/team and internal and external partners
Conduct/support signal detection and evaluation according to SOPs and guidelines
Prepare safety assessments, SERs, as necessary, for potential signals or issues (product quality)
Perform review and summarization of literature citations including epidemiology background research
Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents
Contribute to regulatory agency submissions (Investigational new drug applications, new drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable
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