Time for something new

Safety Surveillance Scientist

Are you experienced in the pharmaceutical industry? Would you like to join a multicultural team of over 100+ professionals which develops a new drug that helps humankind live freely? We are starting a new project in Pharmacovigilance, which is a reasonably new business area in Hungary.

Responsibilities:

  • Assisting physicians in maintaining up to date knowledge of the products assigned with focus on safety.
  • Revising aggregate case reports from the relevant safety database and other sources as applicable, using client’s relevant designated safety surveillance tool.
  • Conducting initial evaluation of safety signals from routine review of cumulative safety data and document outcome according to specified criteria and requirements.
  • Documenting potential signal and related information as per specified criteria and requirements. Maintaining surveillance action log up to date.
  • Preparing training material, conduct and assess periodic and need based trainings as and when required.
  • Ensuring compliance with global and local procedural documents and local implementation of the client Patient Safety objectives, policies, procedures and processes.
  • Notifying surveillance team of any safety signal that may require urgent evaluation and action.
  • Conducting further evaluation of safety signal as required by the client, if applicable
  • Providing ongoing training on the updated SSP, routine signal management requirements, product safety profiles and updated safety signal evaluation criteria for new hires.
  • Participating in conducting gap analysis and identify the remedial actions for the improvement of quality of deliverables as and when required.

Requirements:

  • Healthcare professional (Life sciences Graduate and Post-graduate) with more than one year of Pharmacovigilance experience at a Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities.
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
  • Knowledge of drug safety and clinical development and ICH/GCP principles.

Advantage:

  • Knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation.
  • Knowledge of global Pharmacovigilance regulatory requirements.

What we offer:

  • Being part of the Top 10 Pharma company partner
  • Working in an international, young and dynamic team
  • Opportunity to work and deepen your knowledge in the field of Pharmacovigilance – Drug Safety
  • Remote work (Home office)
  • Flexible working hours

Sector (s):

  • Healthcare, Pharmaceutical Industry
  • Healthcare Specialist
  • Pharmacist

Experience required:

  • 1-5 years’ professional experience

Required Qualification:

  • University degree

Required language level:

  • English (higher advanced/fit for negotiation)

Employment type:

  • Full time

If you are interested, send your English CV to

Álláshirdető

Sagáth Zita

szenior recruiter

zita.sagath@foxhr.hu

Zita elsősorban olyan pozíciókkal foglalkozik, ahol a szakmai tapasztalat mellett a kiváló nyelvtudás is fontos szerepet kap, legyen az IT vagy akár jogi terület. Munkapszichológus tudásával és öt év interjúztatásban szerzett tapasztalattal várja a jelentkezőket.