Patient Safety Physician

Job Description:

Responsibilities

• 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

Qualification & Experience    

• 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.)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 but not essential
• Good knowledge/understanding of medical terminology.
• Fresher/ relevant experience in pharmacovigilance/ Drug Safety/clinical practice.