Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects associated with pharmaceutical products or any other medicine-related problems.

CTC’s Pharmacovigilance department has experience in investigational medicinal products (IMPs), advanced therapy medicinal products (ATMP) and medical devices in a wide range of indications and areas of use. The team carries out their work in accordance with EU Clinical Trials Regulation, guidelines for good pharmacovigilance practices (GVP) and other relevant regulations and directives.

The pharmacovigilance services encompass both clinical development and approved drugs and are built on 4 corner stones:

  • Clinical Pharmacovigilance including Safety database
  • Medical Monitoring
  • Clinical Coding
  • Post-marketing Pharmacovigilance

Every medicinal product and medical device must have completed a satisfactorily clinical trial/investigation program establishing acceptable evidence of safety and efficacy before achieving marketing approval or CE marking. The Pharmacovigilance team at CTC offers offer guidance and solutions that align with each customer’s unique requirements in terms of pharmacovigilance services, and the current phase of the lifecycle of a drug or medical device. Our safety management approach includes safety physician availability 24/7 (if needed), SAE/SUSAR handling- and reporting, annual safety report (ASR) writing and setup of a validated safety database. In-house medical monitors may act as the Sponsor’s safety representative and are free of conflict of interest in relation to the clinical trial. We tailor our services to provide suitable and reliable support to your team throughout the drug/device development process.

When a medicinal product reaches the marketing authorisation application/authorisation stage, additional activities are required such as the appointment of a qualified person responsible for pharmacovigilance (QPPV, EU and/or UK), setup of a related pharmacovigilance system master file (PSMF), regular literature searches, signal detection, management and reporting of individual case safety reports (ICSRs), authoring of standard operating procedures, risk management plans, aggregate reports, as well as handling of medical inquiries and product quality complaints. Our personnel are well trained and experienced in both EU and UK pharmacovigilance legislation and have a robust experience from the QPPV role and PV audits and inspections.

Read more about Medical Monitoring, Safety Management, Medical Coding, Safety Committees and Medical Device services within our Pharmacovigilance department.


Cornelia Lif-Tiberg

Anaesthesiologist, medicine physician

Cornelia Lif-Tiberg is a board-certified anaesthesiologist and intensive care medicine physician with extensive experience in the pharmaceutical industry, encompassing roles in both Sponsor organisations and contract research organisations (CROs).

Cornelia’s track-record includes medical responsibility for clinical trials, spanning both CROs (Phase I) and Sponsor organisations (Phase I,II, III). She has broad experience as Principal Investigator in all phases of clinical development and in the field of drug safety/pharmacovigilance/medical monitoring. Currently, she is responsible for the management of CTC’s Pharmacovigilance department, which offers an end-to-end pharmacovigilance solution spanning from clinical development through post marketing surveillance for IMPs and medical devices.


Mario Clementi

Master of Medical Science in Biomedicine

Mario Clementi holds a Master of Medical Science in Biomedicine. He has more than 15 years of experience in Pharmacovigilance in clinical trials and in the post-marketing phase.

Mario has accumulated several years of experience as EU and UK QPPV. In this role he has managed various responsibilities, including the handling of safety signals and marketing authorization applications along with their associated risk management plans. He has also taken part in multiple pharmacovigilance inspections and audits. As a result, he has contributed to develop robust pharmacovigilance systems in the concerned organisations. Currently, he is Associate Director of CTC’s Pharmacovigilance department and work operationally as QPPV.

We provide our customers with cost-effective advice, conduct and reporting of clinical trials.