CASE MEDICAL SAFETY EXPERT (CMSE)

Excelya>Full-time>CASE MEDICAL SAFETY EXPERT (CMSE)

Job description

Established in 2014, Excelya is a ‘people centered’ contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop-shop service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

 

As a Case Medical Safety Expert, in accordance with the company’s strategy, ethics and procedures, you will be responsible for :

Activities & Responsibilities:

Within the Global Pharmacovigilance (GPV) – Case Management Unit, the Case Medical Safety Expert (CMSE) has a leadership role in the expertise and management of ICSRs on assigned therapeutic areas / products.

The main responsibilities / activities of the CMSE are:

  • Supervision of the medical review of ICSRs, with a particular focus on the medical accuracy and documentation of ICSRs, implementation and enforcement of the ICSR routine monitoring plan and identification of findings.                                                           
  • Participation in cross-functional projects and meetings within GPV or with clinical teams, being the point of contact for ICSR management and providing expertise on medical assessment, sharing safety information, representing case management positions/processes and Periodic Review of non-serious events.

Profile required:

  • Pharmacist or physician with at least 5 years of pharmacovigilance experience, ideally corporate, in the management and medico-regulatory evaluation of individual pharmacovigilance cases, both clinical and spontaneous
  • Extensive PV, Medical and Regulatory knowledge
  • Autonomy, ability to give feedback and share ideas, ability to prioritise activities, ability to work in a constantly changing environment with obligations, ability to demonstrate a high quality of work, and a taste for teamwork
  • Knowledge of PV databases with expertise in MedDRA coding, and proficiency in MS Office programs
  • Very good level of working English (verbal and written)

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