Patient Safety Physician

Location: Prakāshamnagar

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.

Key Accountabilities

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 for…