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 under guidance of senior physicians.
- Attending and/ or presenting at client/cross functional meetings along with other stakeholders under guidance of senior physicians.
- Developing knowledge of global regulatory requirements and reporting obligations
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 established client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client under supervision
- 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 under supervision
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), under supervision
- Review 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 under supervision
- Review 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.
- Review 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) under guidance from senior physician
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 under guidance
Signal Detection and Management (as applicable)
- Supporting signal detection activities under supervision 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 under supervision
- Support preparation of SERs, perform case analysis, review literature summaries, check draft for medical and scientific accuracy and cohesiveness
- Support responses to HA requests and other safety documents
- Providing relevant medical 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.).
- Attend Safety Management Team (SMT) meetings present data/analysis under supervision.
Skills:
- Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
- Ability to work within defined procedures and practices to determine appropriate action
- Developing knowledge of drug safety, clinical trial and pharmacovigilance principles
- Good presentation and verbal/written communication skills.
- Demonstrates potential for technical proficiency, scientific creativity, and collaboration
- Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps.
- A flexible attitude with respect to work assignments and new learnings.
- Good understanding of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines.
Knowledge and Experience:
- Experience in pharmacovigilance and medical data review activities is desirable but not essential
- Good knowledge/understanding of medical terminology.
- Fresher/ 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.)