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.
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.)
