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 aggregate reports and for various signal management activities

Provide medical guidance to PV team/study team

• Provide medical guidance to safety staff during the case processing cycle
• Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs)
• Provide medical input into Pharmacovigilance workflows and projects under guidance

Skills:

• Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
• Ability to work within defined procedures and practices to determine appropriate action
• Developing knowledge of drug safety, clinical trial and pharmacovigilance principles
• Good presentation and verbal/written communication skills.
• Demonstrates potential for technical proficiency, scientific creativity, and collaboration
• Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps.
• A flexible attitude with respect to work assignments and new learnings.
• Good understanding of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines.

Knowledge and Experience:        

• Experience in pharmacovigilance and medical data review activities is desirable
• Good knowledge/understanding of medical terminology.
• Relevant experience in pharmacovigilance/ Drug Safety/clinical practice. 

Education:

• Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
• Completion of at least basic training in clinical medicine (residency, internship etc.)