Patient Safety Physician

Overview

Patient Safety Physician performs medical, safety monitoring or pharmacovigilance activities for assigned projects under guidance. They contribute to medical review, analysis of data and provide input to safety reports following established procedures and guidelines.

General

• Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
• Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee
• Interacting with internal and external stakeholders for resolving issues under guidance of senior physicians.
• Attending and/ or presenting at client/cross functional meetings along with other stakeholders under guidance of senior physicians.
• Developing knowledge of global regulatory requirements and reporting obligations

Case report medical review (as applicable)

• Performing medical review of cases not limited to (including non-serious and serious spontaneous (including legal cases), clinical trial, and literature cases including combination products {drug-device) according to established client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client under supervision

• Writing Pharmacovigilance/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

• Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
• Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
• Identify and resolve case issues, coordinate with client therapeutic/legal team under supervision

Medical monitoring (as applicable)

• Answering day-to-day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), under supervision
• Review adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities
• Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
• Provide medical safety expertise to client under supervision

• Review Data Management line listings (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication, efficacy end points), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator.
• Review technical documents written by Parexel with respect to medically relevant matters with particular attention to those relating to patient safety
• Review coding of adverse events, medical history and concomitant medications for accuracy and consistency
• Review of patient profile report as needed
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other Parexel departments
• Attend and present material as requested, at internal and external meetings (e.g., investigator meetings, therapeutic area training, Regulatory Authority meetings) under guidance from senior physician

Literature review (as applicable)

• Review of literature for product safety assessment and potential safety issues
• Expert in reviewing literature references including triaging, summarizing and providing MAH comments…