Candidates

Pharmacovigilance or Drug Safety Scientist

Serious Adverse Events (SAEs) occurring in a clinical trial or after a product is in the marketplace must be collected and reported to the regulatory authorities. Since 2005 reporting has had to occur electronically via reporting tool called Eudravigilance.

The EU requires a Qualified person to be appointed in every company to take ultimate responsibility for this process.

Working in the Pharmacolvigilance department requires a keen eye for details and an understanding of medical terminology as you will be responsible for monitoring the SAEs, entering the details into the companies database and writing SAE narratives and reports for the relevant authorities.

You may also be asked to write Periodic Safety Update Reports (PSURs) which are reports that are submitted to the regulatory authorities containing all of the relevant clinical and non-clinical safety data for the period of reporting.

Patient safety is one of the most important things to pharmaceutical companies so drug safety departments work in collaboration with the other departments including Clinical operations , Medical information, regulatory affairs and data management.

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Job of the week - Senior Contract Regulatory Professional

Our client is a leading Pharmaceutical company. This R&D group have a large and dynamic European Regulatory Affairs Department responsible for the regulatory affairs work for the CNS R&D in Europe, Turkey, CEE region, Israel, South Africa, New Zealand and Australia.

The work has several aspects;

  • Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical;
  • Working with the local operating companies within the^allocated region and external communication to regulatory authorities in the regions and to the EMEA. The group covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. The prime responsibility for compounds is with the European Regulatory Liaison (EURL) who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.Regulatory consultants will work for an EURL or a global regulatory leader in the CNS therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time. Their work will be assigned and monitored by the EURL or theglobal regulatory lead responsible for the consultant.Eligibility to work in the EEA is required