Our team consists of physicians with huge clinical experience who, in addition, are high level professionals in the field of pharmacovigilance, safety surveillance and risk management, signal detection, aggregate reports review, and ICSR. We are able of providing acme quality pharmacovigilance services to pharmaceutical companies to meet high regulatory requirements.
Product Literature Reviews
- Routine Literature Review for detection of Safety Signals
- Ad hoc comprehensive Literature Review for designated safety signal as requested
- Review, analyze and develop conclusions based on sound scientific and medical knowledge and with reference to the existing product label
- Provision a summary report of the review to the client
Case/Case Series Reviews
- Review, analyze, synthesize Individual Case Safety Report (ICSR) and narrative line listing data, and/or develop conclusions
Aggregate Data Review
- Support signal evaluation and data review
- Review of Argus© safety database including a detailed review of relevant individual records in support of signal evaluation
- Provision of support to Health Authority (HA) safety queries, label updates, scheduled and ad-hoc safety reports/safety updates including signal validation/evaluation reports
- Periodic case reviews in Empirica©
Comprehensive Review of Published and Pre-publication Literature Resources
- Review, assess, summarize relevant articles
- Identify articles that require immediate escalation based on benefit/risk of the product, critical event, medical judgment
- Inform the client with a summary and conclusion of the article
- Identify articles for inclusion in PSUR/PBRER – write summary for PSUR/PBRER
- Identify, assess and summarize relevant articles based on pre-determined event of interest for the product
Ad Hoc Literature Searches
- In collaboration with the client safety and library personnel, develop search strategy for ad hoc requests
- Review and assess output; identify relevant articles, summarize and present results
Individual Case Safety Reports
- Intake and Triage
- Monitor the receipt of ICSR from the sponsor/client
- Provide an acknowledgement (applicable for both initial and follow up information) on the receipt of ICSR as defined or as agreed or as per client expectation
- Perform a meticulous and exhaustive duplicate search as per the defined work instruction to ensure no duplicate entries are made in the safety database
- Notify the sponsor if the any report deemed to be a duplicate
- Review the source document for valid case criteria, follow-up information and information adequacy
- Request for follow-up information, if required
- Case creation
- Provide initial seriousness assessment for a case, categorizing the case type, assigning the case priority, coding events, product and relatedness information
- Responsible for completing the Intake and Triage activities in safety database within the stipulated time
- Update the assigned trackers
- Work closely with case processor/Lead/Project Manager for daily operations
- Data Entry (Case Processing)
- Perform duplicate search as per the defined work instruction to ensure no duplicate entries are made in the safety database
- Verify the initial data entry done at the triage step as per the inhouse/ client SOP’s/ guidelines to ensure the quality
- Request for clarifications if information is not available/not adequate/not clear
- MedDRA coding, medical history, events, laboratory details using the latest MedDRA version
- Code product and concomitant medication details (WHODrug Global)
- Perform labelling and causality assessment
- Prepare a narrative as a stand-alone information covering all the relevant information pertaining to the case
- Responsible for completing the case processing activities in safety database within the stipulated time
- Ensure timely and appropriate regulatory submissions
- Provide feedback to Triage person on the errors/ discrepancy noted
- Update the assigned trackers
- Participate in Process Improvement Initiatives to keep up the Quality and Compliance score
- Medical Review
- Perform medical review of non-serious, serious and potentially serious ICSR with emphases on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Involve in process improvement activities like implementation of quality control process
- Provide medical guidance and expert opinion on the cases to the Data entry associates peer reviewers to help resolve queries
- Identify and resolve case issues, coordinate with client therapeutic teams and within Functional Team Management as appropriate
- Maintain PV expertise, and understanding of international safety regulations and guidelines
- Provide strategic and proactive safety input into development plans
- Support due diligence activities and pharmacovigilance agreements
- Responsible for completing the QR activities in safety database within the stipulated time
- Provide feedback to case processors on the errors/ discrepancy noted
- Ensure timely and appropriate regulatory submissions
- Update the assigned trackers
- Participate in Process Improvement Initiatives to keep up the Quality and Compliance score