PVMantra's Pharmacovigilance Services provide a crucial framework for ensuring the safety and efficacy of pharmaceutical products. With a team of highly skilled professionals, PVMantra offers comprehensive solutions to monitor and evaluate the adverse effects of drugs, and ensuring compliance with regulatory requirements. PVMantra conducts thorough pharmacovigilance activities, including adverse event reporting, signal detection, risk management, and safety monitoring.
By providing accurate and timely safety information, PVMantra's pharmacovigilance services contribute significantly to patient safety and enable pharmaceutical companies to make informed decisions regarding the benefit-risk profile of their products.
This process is for understanding the relationship of any adverse event(s) reported in the case reports after the cases are processed into the validated safety database.
Clinical history provided in the case along with all medications used prior to advent of adverse event have to be used in evaluating the case thoroughly to establish the causal relationship between the event and the reported drug.Information about the usage of other drugs will help the physician understand if there is any drug-drug interaction leading to the emergence of adverse event reported.
Clinical history will be used to understand if there are any confounding factors influencing the outcome of assessment of causality relationship.
PVMantra’s medical team are qualified and experienced medical doctors, will assess the cases thoroughly for seriousness, causality association, listedness / labelledness, coding using medical dictionary like MedDRA and pass medical comment to close the case for submission. Medical reviewers proactively assess the cases to identify any signals in the case and any new information found can be used to assess the risk management strategy currently in place and formulate additional / new safety measures.
Medical reviewers actively analyse Summary of Product Characteristics (SmPCs), Product Leaflets, Prescribing Information, Investigator’s Brochure (IB) etc as need be to arrive at a logical conclusion.
Case processing activity at PVMantra involves collection and processing of cases that are either in the clinical development phase or in post-authorisation phase.
PVMantra’s qualified associates are trained on latest drug safety regulations of various health authorities. The team manages safety information for all drugs by tracking SAEs (Serious Adverse Events), ADRs (Adverse Drug Reactions) that could be serious and medically significant and process those cases for reporting to the health authorities complying with the timelines set by the health authorities. The team uses computerised systems for data collection for the triage process before the data from those cases is entered into health authority validated database at data entry phase.
Coding is done for adverse events, for drugs, assessment is done for establishing causal relationship and listed / expectedness using documents such as labels.
Narratives will be written in the database based on the information available and all these cases are reviewed in quality review step before pushing them for medical review and prepare them for submission to regulatory authorities.
These cases are stored in the database for further usage.
Aggregate reports are generated in order to assess the benefit-risk profile of the drug. These are required to be submitted to the health authorities at regular intervals as defined in their guidance documents.
PVMantra team prepares schedules and in a scientific synchronised manner the team collects data and information from all stake holders, refer to information published by health authorities and prepare the reports for submission. The team is experienced in writing reports like PSURs / PBRERs, CSRs, Bridging reports, and any kind of report that is required by the health authority.
The aggregate reports are useful to understand comprehensively of the safety profile of the drug and to assess the need for updating the safety information of the product.
This is an essential activity that should be performed by the pharmaceutical company to make sure all risks associated with their medicines are properly addressed so that the benefit risk profile remains positive.
Various documents like Risk Evaluation and Mitigation Strategies for the FDA and Risk Management Plans for EU and other geographies are to be constantly reviewed and updated on time. Medical team at PVMantra are highly knowledgeable for evaluating and authoring these reports in a timely manner.
We can identify and characterise the safety profile of drugs and as per the health authorities guidelines, can plan activities for risk characterisation and new risk identification. We can plan and implement mitigation or minimisation strategies and continuously assess the effectiveness of these strategies in the risk management cycle.
The team will author the required documents as per the recommended guidelines for submission and approval. This team works together with the other teams in PVMantra and in client companies for effective exchange of information in a timely manner and can interact with the health authorities if there are any queries on behalf of the client.
PVMantra's Risk Evaluation and Mitigation Strategies (FDA) Services are designed to assist pharmaceutical companies in navigating the complex landscape of FDA regulations. With a deep understanding of the industry, PVMantra offers comprehensive risk evaluation and mitigation strategies to ensure compliance and patient safety. Their expert team conducts thorough assessments of potential risks, identifies areas of concern, and develops tailored mitigation strategies.
By partnering with PVMantra, pharmaceutical companies can confidently navigate the regulatory process, mitigate risks effectively, and ensure the safe and successful launch of their products. With PVMantra's FDA services, companies can focus on their core competencies while leaving the regulatory complexities to the experts.
This activity is required to be performed by the pharmaceutical company rigorously and regularly to identify new safety concerns and evaluate them scientifically with all available information to make sure the benefit-risk profile remains positive for their products.
The information gathered during case processing of individual cases might not be sufficient to clearly attribute the causal relationship between the drug and the adverse event reported.
All cases processed into the database will be taken as line listings by PVMantra’s expert team and checked for information like seriousness of the event, dechallenge, rechallenge, outcome of the event etc, the safety event reported can be considered for further evaluation for signal.
The qualified team at PVMantra will use approved statistical models and software to analyse the data available to identify new signals, validate them, analyse them, their assessment and their management.
PVMantra's QPPV (Qualified Person for Pharmacovigilance) services are designed to ensure compliance with regulations and provide expert oversight in pharmacovigilance activities. As per regulations, PVMantra offers the expertise of experienced QPPVs who take responsibility for the company's global safety surveillance and reporting obligations. With in-depth knowledge of international regulations, PVMantra's QPPVs ensure that adverse events and safety concerns are appropriately monitored, documented, and reported to regulatory authorities.
By partnering with PVMantra for QPPV services, pharmaceutical companies can confidently meet their pharmacovigilance obligations, maintain compliance, and safeguard patient safety.
PVMantra's QPPV services provide the necessary expertise and support to navigate the ever-evolving landscape of pharmacovigilance regulations.
In addition to the various sources of cases like literature or spontaneous reports, call centres play a major role in collection of data on adverse events or reactions from the reporters like pharmacists, patients, care givers or even health care professionals like doctors, nurses etc
PVMantra’s team is experienced in addressing the queries related to your products, collect information such as suspect drug, its dose, and the reaction / event and also manage the mailbox to identify the types of cases and channel them appropriately for appropriate analysis like entry into the database and to identify safety concerns.
The team is also experienced in following up for more information in case there is a need and pass the information to the teams in a timely manner for updating the cases in the database.
PVMantra can also set up a call centre for you including contact number so that all queries can come to one central location without much burden on you.