Pharmacovigilance

Safeguarding patients & products throughout their life cycle

Pharmacovigilance ensures that medicines remain safe and effective once they reach patients. From individual case assessments to aggregate signal detection and regulatory reporting, expert medical input is essential to interpret data accurately and communicate findings responsibly.

At CLT Vigilance Consulting, pharmacovigilance support provides independent, medically qualified expertise to strengthen safety evaluation, support QPPV functions, and ensure that safety decisions are both clinically sound and regulatorily robust.

Core activities include:

Medical review of Individual Case Safety Reports (ICSRs), including assessment of causality, seriousness, and expectedness.
Supporting QPPV functions with medically qualified input.
Contributing to signal detection activities and evaluating potential safety signals from a medical perspective.
Evaluating cumulative safety data, trends, and emerging safety concerns.
Contributing to regulatory reports such as Annual Safety Reports (ASR) and Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports (PSURs / PBRERs).
Collaborating with cross-functional safety teams and external partners.

Value to client

CLT Vigilance Consulting provides focused, physician-led pharmacovigilance support, grounded in the expertise of Cornelia Lif-Tiberg, MD.

Combining clinical judgment with regulatory precision, this approach enables sponsors and CROs to maintain compliance while ensuring that safety assessments, signal evaluations, and regulatory communications remain medically sound, consistent, and defensible.

Independent medical review adds an additional layer of quality and objectivity — strengthening both internal decision-making and external credibility.