Pharmacovigilance Services

Safeguarding Lives, Empowering Insights: Your Trusted Pharmacovigilance Partner

With a strong global footprint, SafeVig offers extensive clinical and post-market safety services encompassing various capabilities. These services include proficient aggregate report writing, effective signal detection and management, comprehensive global literature surveillance, robust risk management, and efficient case processing and reporting. Our comprehensive suite of services ensures that our clients receive holistic support throughout the entire lifecycle of their products, fostering safety and compliance in the ever-evolving regulatory landscape.

Our comprehensive pharmacovigilance services offer a seamless continuum of activities and processes that guarantee the utmost safety and monitoring of pharmaceutical products throughout their lifecycle. From meticulous data collection to thorough assessment and proactive management of adverse drug reactions (ADRs) and other safety-related information, we provide end-to-end solutions to ensure the highest standards of drug safety and patient well-being.

SafeVig provides below Pharmacovigilance solutions:

  • Drafting of Safety Management Plan.
  • Case Intake and Intake Reconciliation.
  • Case processing.
  • Narrative generation.
  • Query follow-ups with investigators.
  • SAE reconciliation with clinical database.
  • Analysis of Similar Events (AOSEs) etc.
  • Medical Information call center services.
  • Databasing of Adverse Events of Special Interests (AESIs).
  • Aggregate Report authoring of PSURs, DSURs, ASRs, PBRERs and PADERs.
  • Aggregate Report Submissions.
  • QPPV services.
  • PSMF preparation and management.
  • Risk Management Plan drafting and management.
  • Medical Monitoring.
  • Regulatory intelligence.
  • Global and local literature surveillance.
  • Regulatory Submissions through Gateway and Web trader.
  • Signal Reports preparation.

SafeVig also provides below vigilance services:

At SafeVig, Our dedicated team of scientific, medical, and quality assurance professionals collaborates globally, enabling us to offer comprehensive guidance and assistance in updating Standard Operating Procedures (SOPs) and working practices that effectively support Pharmacovigilance (PV) activities. Additionally, we possess the expertise to facilitate developing and delivering PV training programs for all employees.

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