Patient safety and product efficacy are the two most crucial factors that undergo constant scrutiny even after market entry, and ensure the fortune of a pharma manufacturer’s sustainability in the market. Periodically, manufacturers are liable to report their product’s safety and efficacy levels to the health authorities. There is a need for a Pharmacovigilance expert. PV is no longer just a checkbox; it is a strategically driven function that identifies, evaluates, and prevents adverse events. It minimizes risks and accelerates product life cycle management, hence protecting brand reputation.
We at Vigilare ensure that compliant Pharmacovigilance procedures are integrated across the product life cycle. From signal detection to ICSR case processing, and aggregate report writing to submissions, our expert team focuses on managing global compliance. Our ultimate goal is to promote the safe and effective use of pharmaceutical products, and to ensure that patients receive the highest quality of care.
To support robust safety analysis and reporting, we collect and ensure the clinical data is clean, validated, and regulatory-compliant. Aligning with ICH-GCP and CDISC standards, we provide CDM services that span across CRF design & Preparation, Database Design & Setup, AE/ASE Reconciliation, Electronic Data Capture, Medical Coding (MeDRA & WHO DD), Data Entry & Integrity Check, Database Validation and Query Management, Database Cleaning, etc.
The first possible way to avoid any Adverse Event (AE) is to educate the end-user about the safe and effective usage of a drug or device. With a perfect amalgamation of medical accuracy and marketing clarity, we offer Medico Marketing Support through Continuous Medical Education (CME) programs, Market Surveys, and Key Opinion Leader (KOL) Communication Strategies, Creating Patient Education Material and Scientific Narratives.
We believe quality is the only reliable factor in healthcare that can build customer trust. To ensure it is in line with the highest health authority standards, and to prepare organizations for end-to-end compliance and inspection readiness, we provide GCP and GLP audits, Investigator Site Audits, Vendor Audits, SOP Management, and Quality Systems Training and Development.
We support pharmacovigilance (PV) activities across all phases of clinical trials right from collecting safety data to handling Serious Adverse Events (SAEs)/Adverse Events (AEs). Our experienced team at Vigilare ensures safety surveillance is seamless and leverages integrated systems for regulatory reporting with zero errors. Our expertise lies across studies of healthcare and modern medicine including Oncology, Cardiology, Dermatology, Nephrology, Neurology, Gastroenterology, Orthopedics, Gynecology, and more.
Apart from quality, time is crucial to ensure quick market access for a medicinal product or medical device. We, at Vigilare, act as your authorized local agent to expedite product approvals. We extend support from documentation to distribution and ensure timely submissions, ongoing compliance, and a seamless interface with local health authorities. We are proven to be an end-to-end US agent for one of the growing Pharmaceutical companies.
Post-approval PV obligations include submitting 15-day expedited reports for unexpected serious adverse events, annual Periodic Benefit-Risk Evaluation Reports (PBRERs), maintaining a Pharmacovigilance System Master File (PSMF) in the EU, implementing Risk Management Plans or Risk Evaluation and Mitigation Strategies in the US, and ensuring a qualified person for PV (QPPV) is in place. Non-compliance can result in product suspension or regulatory action.
For small biotechs without in-house PV infrastructure, outsourced PV support provides a fully operational safety system from day one, covering case intake, medical review, signal detection, literature monitoring, and regulatory reporting. This is significantly more cost-effective than building an internal team. Consultants can also serve as the EU QPPV and US Safety Contact, fulfill ICSR submissions to FDA MedWatch, EudraVigilance, and VigiBase, and prepare PSURs and RMPs ready for submission.
A Pharmacovigilance System Master File (PSMF) is a detailed description of the pharmacovigilance system used by a Marketing Authorisation Holder (MAH) for all authorised medicinal products in the EU/EEA. It is required under EU Regulation No 520/2012 for all MAHs operating in Europe. The PSMF must be kept up to date, maintained at the QPPV location, and submitted to authorities upon request. Regulatory PV consultants can draft, maintain, and audit the PSMF on behalf of the MAH.
Signal detection is the process of identifying new or changing safety information that may require regulatory action. It involves mining spontaneous adverse event databases such as FDA FAERS and EudraVigilance using statistical methods like PRR and ROR. The EMA GVP Module IX requires signal detection activities at defined frequencies, typically monthly for newer products and quarterly for more established ones, with outputs reviewed by the QPPV and documented in the signal management process.