[Hiring] Senior Physician, Patient Safety @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Qualifications

• Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)
• 2+ years of experience in ICSR Medical Review
• Completion of at least basic training in clinical medicine (residency, internship etc.)
• Good knowledge/understanding of medical terminology
• Relevant experience in pharmacovigilance/Drug Safety/Clinical Practice

Requirements

• 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
• Attending and/or presenting at client/cross functional meetings along with other stakeholders
• Working as Subject Matter Experts (SMEs)
• Assisting the Project Lead/Functional Lead for audits and inspections
• Providing inputs for process improvements
• Working closely with Project Lead/Functional Lead for process coordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
• Functioning as pharmacovigilance representative/safety scientist
• Attending/supporting Bid defense meetings
• Actively mentoring Patient Safety Physicians to develop their skills and expertise

Case Report Medical Review (as applicable)

• 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 Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
• Reviewing 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)
• Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, reviewing narrative
• Identifying and resolving case issues, coordinating with client therapeutic/legal team
• Providing guidance to junior physicians on case assessment methodologies

Knowledge and Experience

• Experience in pharmacovigilance and medical monitoring activities desirable but not essential

Education

• Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD) / Medically qualified from an acknowledged Medical School