Principal Physician, Patient Safety

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
• 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, Act as a Subject Matter Expert during Audits/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 junior physicians
• Providing thought leadership in specific therapeutic areas

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 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

Periodic reports (as applicable)

• 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

Medical monitoring (as applicable)

• 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)

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

CSR Narratives (as applicable)

• Performing medical review of Clinical study report narratives according to the client’s guidelines and SOPs

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 as required
• On an as-needed basis, provide support in mentoring or training of new hired physicians

Signal Detection and Management (as applicable)

• Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities
• Perform signal validation activities
• Author/review SERs. Perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness
• Author/review responses to HA requests and other safety documents
• Providing oversight and relevant inputs to Medical Writers (MWs) authoring SERs, Signal validations etc.
• Managing safety signals on project specific tools (e.g., Signal Tracking System, Signal management tools, etc.)
• Contribution to Safety Management Team (SMT) meetings: Data analysis/ review, content creation, presentation/ facilitation, drafting of meeting minutes
• Leading signal detection activities and providing expert assessment
• Proactively manage, communicate and escalate as appropriate, potential safety signals associated with marketed products to the relevant stakeholders

Brand Safety Physicians (as applicable)

• Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy, and highlighting and tracking potential issues
• Support the preparation and maintenance of Risk Management Plans
• Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels and Development Core Safety Information (DSCI)
• Coordinate safety activities between Drug Safety Unit/team and internal and external partners
• Conduct/support signal detection and evaluation according to SOPs and guidelines
• Prepare safety assessments, SERs, as necessary, for potential signals or issues (product quality)
• Perform review and summarization of literature citations including epidemiology background research
• Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents
• Contribute to regulatory agency submissions (Investigational new drug applications, New drug applications, Marketing authorization applications, Variations and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
• Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable

Therapeutic Area Expert (as applicable)

• Serve as a subject matter expert within the designated Therapeutic Area, providing specialized knowledge to support drug safety initiatives and decision-making processes
• Collaborate with the TA Lead to implement strategic plans and enhance the overall expertise within the Therapeutic Area
• Contribute to the development and delivery of targeted training programs, elevating the knowledge base of fellow physicians and cross-functional teams
• Actively participate in internal and external scientific forums, representing Parexel's medical expertise through presentations, publications, and thought leadership activities
• Apply deep therapeutic knowledge to optimize pharmacovigilance processes, ensuring best practices are followed and continuously improved
• Mentor junior physicians within the TA, fostering their professional growth and encouraging their contributions to the field
• Support the TA Lead in identifying emerging trends and potential opportunities for innovation within the Therapeutic Area
• Engage in cross-functional projects, offering expert guidance to enhance the quality and efficiency of drug safety assessments

Therapeutic Area Lead (as applicable)

• Provide technical leadership in developing and advancing the Therapeutic Area, aligning initiatives with organizational objectives
• Contribute to the development and implementation of comprehensive training programs for TA physicians and cross-functional teams
• Foster a culture of continuous learning and professional growth, empowering TA physicians to cultivate and leverage their expertise in alignment with business needs
• Champion knowledge sharing by encouraging TA physicians to contribute to scientific discourse through conference presentations, publications, and internal forums
• Drive operational excellence by guiding TA physicians in optimizing pharmacovigilance processes and adopting industry best practices
• Elevate Parexel's medical expertise through active participation in internal and external platforms, including therapeutic area meetings, educational content development, and thought leadership initiatives.
• Collaborate effectively with various internal stakeholders, including other TA leads and corresponding Global Medical Sciences TA leads, to ensure alignment and synergy across therapeutic areas and departments

Line Management (when assigned)

• In addition to technical expert responsibilities, may be assigned line management duties including:
• Supervise and mentor direct reports, including training, professional development, and performance evaluations"
• Provide guidance to ensure team performance meets business and personal goals
• Oversee execution of core deliverables
• Ensure communication of important decisions/policies to team members
• Hold regular team meetings and identify areas of concern
• Identifying and addressing any inter-personal issues within the team
• Propose creative solutions for shifting timelines and staffing requirements to the management

Project Management/Leadership (if applicable)

• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks. Monitor progress of each individual project task and assess the overall program
• Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget
• Keep client and team informed of project status
• Propose creative solutions for shifting timelines and staffing requirements to the management
• Oversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects. Ensure appropriate changes in scope are executed
• Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence
• Implement quantitative measures of performance (key performance indicators)

Skills:

• Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
• Expertise in drug safety and the drug development process
• Demonstrated success in technical proficiency and scientific creativity
• Ability to work on complex problems requiring in-depth evaluation
• Ability to exercise judgment within broadly defined practices and policies
• Good presentation and verbal/written communication skills
• Good interpersonal skills
• Client focused approach to work
• Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
• Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps
• An ability to comprehend various regulatory or client requests and be able to strategize a handling approach
• A willingness to work in a matrix environment and to value the importance of teamwork
• Expertise in international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines
• Experience in mentoring junior team members
• Works independently on complex problems with minimal supervision
• Exercises judgment within broadly defined practices and policies
• Serves as an escalation point for technical issues
• Medium liability potential with decisions that could have serious impacts
• When serving as Line Manager, makes decisions regarding team workload, task allocation, and performance management within established guidelines

Knowledge and Experience:

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