Principal Drug Safety Physician

Principal Drug Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned projects and contribute to medical review, analysis, and guidance in all required safety reports. Principal Drug Safety Physician is also responsible for providing medical leadership and subject-matter expertise to project teams, business development and pre-award activities. Principal Drug Safety Physician perform is responsible for line management of Drug Safety Physicians and Senior Drug Safety Physicians.

• 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
• Provides inputs for process improvements
• Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
• Function as pharmacovigilance representative/safety scientist
• Attend/support Bid defense meetings
• Contribute to assigned Therapeutic Area and actively support development of scientific & medical expertise
• Mentoring of Drug Safety physicians

• 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 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.
• 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.

• Reviewing and/ or authoring of aggregate reports for medical content and consistency in accordance with client requirements and SOPs.

• Providing medical inputs into, and supporting the preparation of key regulatory documents including but not limited to, Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluation reports (HHEs), etc.
• Clinical Expert Statements and other documents as required

• Answering day to day medical and scientific questions, provide daily medical support to Parexel staff or site (investigator/study coordinator), as needed
• Review and sign off 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 per request
• Review and sign off 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, and Regulatory Authorities

• Review and sign off 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)