PRAVEEN LONICHEN THOMAS

MEDICAL REVIEWER

• Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports.
• Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement
• Evaluate adverse event report for seriousness, listedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents are included and provide causality assessment.
• Perform final check of the case and provide medical sign off on the case.
  • Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist.
• Work and interact extensively with relevant stakeholders to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
• Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices.

DATA ENTRY:

• Data entry of adverse events, adhering to scientific rigor and prioritizing timeliness and quality.
• Evaluate the overall seriousness of cases based on seriousness criteria defined by regulatory authorities and the International Medical Evaluation (IME) list.
• Take responsibility for coding various elements, including adverse events, medical history, laboratory data, indications, etc., using standardized medical coding dictionaries like MedDRA or following client guidelines.
• Coding products (suspect/co-suspect, concomitant) in accordance with client conventions and regulatory requirements.
• Drafting case narratives.
• Performing labelling for both serious and non-serious cases.
• Assessing non-expeditable adverse event reports, ensuring completeness and accuracy in data entry of such reports.
• Identifying any missing clinically relevant information from case reports and facilitate its collection.
• Collaborating with internal teams to obtain the necessary information for day-to-day operations.
• Meeting client expectations of daily workload targets, following process flows within agreed service levels, and maintaining data integrity as per client guidelines.
• Prioritizing cases as appropriate or as directed by client to meet internal and external timelines for Regulatory submissions and other deliverables.
• Requesting for follow-up information by using relevant questionnaire.
• Managing special requests for case processing prioritization (e.g., emails from clients regarding cases that must be processed urgently upon receipt of email notification).
• Following standard operating procedures (SOPs) and work instructions related to case processing.
• Adhering to pharmacovigilance regulations, guidelines, and internal policies to ensure compliance and data integrity.
• Understanding adverse event reporting requirements and compliance with data privacy regulations is important.

CASE INTAKE

• Verify the validity of the case by establishing the minimum criteria for creating a case.
• Conduct a duplicate search in the safety database to determine whether an initial case or a follow-up case should be created.
• Identify serious adverse events and special scenario cases, such as lack of efficacy, exposure, pregnancy cases, at-risk cases, and cases solely related to product quality complaints.
• Attach relevant source documents or any safety information, queries, or follow-up information that pertains to the case.
• Apply appropriate coding to all suspected products according to client guidelines.
• Facilitate follow-up actions in response to queries from data entry, quality control, medical review, or if inconsistent or missing information is found in the source file.
• Identify any clinically relevant information that may be missing from case reports and assist in collecting it.
• Perform PVA check for suspect drugs and take appropriate actions based on PVA requirements.
• Coordinate the translation of non-English source documents to client affiliates, if such documents are received in the mailbox.
• Assess the overall seriousness of the case based on client instructions.

• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
• Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
• Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Liaised with clinical project leader to effectively resolve study-related issues.

• Reviewed clinical trial documents for completeness, consistency, accuracy and ensured data integrity through ALCOA.
• Filling and archiving of quality checked clinical trial documents in eTMF and maintainence.
• Maintainence of regulatory documents-Site and Country level along with operational and administrative support.
• Performing periodic eTMF file reviews for quality check of the clinical trial documents in core, country and site level, also provide health metrics for further clinical team actions.
• Resolving or fixing of action items.
• Assisted the clinical team in preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard working procedures.
• eTMF platformed used were ELVIS and WINGSPAN.

CLINICAL TRIAL MANAGEMENT SYSTEM:

• Document tracking.
• Site contracts tracking.
• Regulatory and ethics committee document submission.
• Updating site staff contact list.
• Supported for investigator and site payments.