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
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
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 require
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
Provide guidance to junior physicians on case assessment methodologies

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
Review reports assessed by junior team members for accuracy and completeness

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
Training and mentoring junior team members on signal detection methodologies

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

Skills

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex tasks requiring in-depth evaluation
Good knowledge of drug safety and the drug development process
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
Computer proficiency, an 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
Experience mentoring junior team members
A flexible attitude with respect to work assignments and new learnings
An ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
An ability to assess the clinical relevance of medical data and to interpret its clinical meaning is essential
A willingness to work in a matrix environment and to value the importance of teamwork
Strong knowledge of international drug regulation including ICH GCP, GVP, and all other applicable regulations and 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.)

Senior Physician, Patient Safety