Pharmacovigilance Services

PV Services

Adverse Event Reporting & Management

We offer comprehensive adverse event reporting services, including the collection, documentation, and evaluation of adverse events and product complaints. Our dedicated team ensures timely and accurate reporting to regulatory authorities, sponsors, and ethics committees.

              Safety Signal Detection

We employ advanced data mining and signal detection techniques to proactively identify potential safety signals and emerging risks associated with pharmaceutical products. Our robust signal detection process helps inform risk mitigation strategies and enhance patient safety.

Medical Review & Benefit-Risk Evaluation

We conduct thorough risk assessments and benefit-risk analyses to evaluate the safety profile of pharmaceutical products. Our team assesses the potential risks and benefits of treatment options to support informed decision-making by healthcare professionals and regulatory authorities.

Periodic Safety Update Reports (PSURs)

We deliver meticulously crafted PSURs that comply with global standards, ensuring ongoing product safety and providing regulators with key insights on risk-benefit balance.

Individual Case Safety Reports (ICSR) Processing
We ensure swift and accurate processing of ICSRs, from data entry to regulatory submission, maintaining high data integrity and compliance.

Literature Screening
Our dedicated team systematically screens global scientific literature, identifying relevant safety information to stay ahead of potential risks.

Pharmacovigilance Audits & Inspections
We provide comprehensive audit services to ensure your pharmacovigilance system is inspection-ready, meeting international standards and regulatory requirements.

          Post-Marketing Surveillance (PMS)
Leveraging real-world data, we monitor product safety in post-launch phases, providing insights that safeguard patient health and extend product lifecycle.

       Aggregate Reports Preparation
Our experts create detailed, regulatory-compliant aggregate safety reports, providing a holistic view of drug safety across clinical phases and post-approval stages.

Global Safety Database Management
We manage centralized safety databases with precision, ensuring efficient tracking and reporting of adverse events globally to meet diverse regulatory needs.

Pharmacovigilance System Master File (PSMF) Creation
Our team builds and maintains PSMFs that showcase regulatory adherence, ensuring all aspects of your pharmacovigilance system meet international compliance standards.

Qualified Person for Pharmacovigilance (QPPV) Support
Our qualified QPPVs offer strategic oversight and ensure continuous regulatory compliance across Europe and other regions for your products.

From signal detection to risk management, RCS's experts keep your product's safety profile at the forefront of every step

What makes us unique

• Expertise: Our team of pharmacovigilance experts brings extensive experience in drug safety and regulatory compliance, ensuring the highest standards of pharmacovigilance practice.

• Comprehensive Solutions: We offer a full suite of pharmacovigilance services to support every stage of the drug development lifecycle, from pre-market safety assessments to post-marketing surveillance.

• Patient-Centric Approach: We prioritize patient safety and well-being in all our pharmacovigilance activities, striving to detect and mitigate adverse events to enhance patient outcomes.

• Regulatory Compliance: We adhere to global pharmacovigilance regulations and guidelines, ensuring that our clients remain compliant with regulatory requirements and industry standards.