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Market Complexities Call for an Integrated Approach to Pharmacovigilance

The increasingly complex pharmaceutical market is causing two significant challenges for manufacturers executing pharmacovigilance activities:

  1. Vendor Overload – Brands traditionally use multiple vendors to launch new therapies and provide patient support, but this proves inefficient. Brands now require tailored solutions for accessibility, promotion, affordability, adherence, and product delivery.
  2. Surmounting Cost, Quality, and Timeline Challenges – AE surges, global expansion, shifting regulations, and accelerated timelines raise operational costs and quality concerns.

EVERSANA Integrated Pharmacovigilance Solution

EVERSANA’s Integrated Pharmacovigilance Solution offers a streamlined, cost-effective approach that ensures compliance, by delivering fully processed adverse event cases, and effective use of your product throughout its life cycle. Our solution combines human interaction and AI technology to provide meticulously processed adverse event data that meets all regulatory requirements while expediting case processing to five days and reducing costs per case by 50%. This empowers brands to focus their efforts on what matters most: monitoring the benefit-risk profile and ensuring patient safety.

Transforming Drug Safety Automation

Through the integration of technology and automation within a robust regulatory framework, we expedite data processing, facilitating proactive decision-making in product safety. Our technology infusion introduces real-time predictive intelligence into our pharmacovigilance services, allowing us to efficiently process and analyze safety data. Additionally, we can predict critical signals and risk factors, pinpoint safety concerns, and offer recommendations for optimizing product utilization to enhance patient outcomes.

Our Safety Operations and Pharmacovigilance Services Include:

Case/ICSR Processing

  • Safety Database: Hosted safety databases with client-specific tenancy and electronic records/signature compliant as per 21 CFR Part 11 and Annex Part 11. E2B import and export and electronic gateway capable
  • Post Marketing and Clinical ICSR management: Mailbox set up and monitoring for AE and Safety data. Book-in, Triage, MedDRA coding, data entry, narrative writing, medical review, quality review. SUSAR, AOSE and 15-Day expedited reporting/Submission to Regulatory, Investigators, IRB/EC, etc.
  • Electronic case reporting to relevant regulatory authorities
  • Literature Surveillance and Literature Case Processing: Tailored search that can be applied in global and local databases like Medline, PubMed, and Embase to find safety data and Individual Case Safety Reports (ICSRs)
  • Full understanding of complex devices and combination products regulatory requirements that will allow faster, efficient, and compliant process for such products in safety database for reporting and submission
  • Product Complaint (PC) case management with preliminary determination of reportability, produce complaint documentation and trending of product complaints
  • Case management of medical device reports including medical evaluation

Aggregate Reports

  • Periodic Adverse Drug Experience Report (PADER)
  • Periodic Safety Update Report (PSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Drug Safety Update Report (DSUR)
  • Other reports as required

Signal Identification and Risk Management

  • Comprehensive solution for effective ongoing product safety signal detection, signal identification, evaluation, tracking and monitoring
  • Strategic partnership for all risk minimization activities such as developing risk mitigation or prevention measures. The risk management document such as U.S. Risk Evaluation and Mitigation Strategies (REMS) development and assessments. EU Risk Management Plan (RMP) development.
  • Label management and patient and prescriber communications
  • Drafting responses to regulatory agency and health authority
  • QPPV and LPPV services
  • Audit and Inspection support
  • PSMF, HHR, PLLR, NDA and other such requirements
  • SDEA
  • Support in filing for NDA or any regulatory application

Explore a library of our Pharmacovigilance resources.

  • Vast Industry Experience Experience with top 20 pharma companies
  • Deep Bench of Experts Leadership team with over 20+ years’ experience
  • Reporting Capabilities Direct experience with IND, Annual Report, DSUR, PSUR, Pader Development
  • Integrated Services Dedicated Regulatory group within EVERSANA’s Integrated Compliance Services


Ready to learn more?

Schedule a meeting today.