Senior Physician, Patient Safety; Senior Drug Safety Physician

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post‑marketing settings. In this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance.

As a Senior Physician in Patient Safety, you'll serve as the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with cross‑functional teams, interact with clients, and contribute to the continuous improvement of our pharmacovigilance processes.

• Maintaining a good working knowledge of the adverse event/safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines, 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, or designee
• Interacting with internal and external stakeholders for resolving issues
• Attending and/or presenting at client/cross‑functional meetings along with other stakeholders while acting as subject‑matter experts (SMEs)
• Assisting the project lead or functional lead for audits and inspections
• Providing inputs for process improvements
• Working closely with project lead or functional lead to coordinate processes and ensure meeting all key performance indicators (KPIs)
• Acting as a pharmacovigilance representative/safety scientist
• Attending or supporting bid defense meetings
• Actively mentoring Patient Safety Physicians to develop their skills and expertise

• Performing medical review of cases, including complex and challenging cases requiring expert judgement, clinical trials and literature cases according to client or Parexel SOPs
• Writing pharmacovigilance/marketing authorization holder (MAH) comment and assessing company causality
• Reviewing appropriateness of medical content in narrative for medical coherence
• Assessing seriousness, listability/expectedness of reported events
• Providing medical inputs to case processing team
• Raising appropriate follow‑up queries for relevant information from the reporter/HCP
• Reviewing and verifying appropriate selection of adverse events from source documents, assigning appropriate MedDRA code, reviewing narrative
• Identifying and resolving case issues, coordinating with client therapeutic or legal team
• Providing guidance to junior physicians on case assessment methodologies

• Reviewing and/or authoring aggregate reports for medical content and consistency in accordance with client requirements and SOPs
• Providing medical inputs into and supporting preparation of key regulatory documents including PSURs, PBRERs, SERs, HA response documents, DSURs, COs, ACOs, HHEs, etc.
• Producing clinical expert statements and other documents as required
• Reviewing reports assessed by junior team members for accuracy and completeness

• Answering day‑to‑day medical and scientific questions, providing daily medical support to Parexel staff or site investigators or study coordinators
• Reviewing and signing off adverse events reports for accuracy and clinical importance, assessing relationship to the study drug, severity, and seriousness; providing sponsors with periodic experience reports summarizing adverse events as required
• Attending and presenting material (such as therapeutic area training) at internal and external meetings (e.g., investigator meetings)
• Providing medical safety expertise to client upon request
• Reviewing and signing off data management line listings, establishing presence or absence of clinically…