Safety Surveillance Physician 1-year Fixed term position

ES-13998

Jelentkezem az állásra

Come and join a brand new project of our multinational partner and take your part in supporting one of the world’s most prestigious pharma companies developing a new medicine! If you studied or worked before in the pharmaceutical industry, we are waiting for you! Please note that this is a one year long project and we can only go on with applicants who has valid work permit to work in Hungary.

Location: Budapest

Responsibilities:

  • To ensure compliance with global and local procedural documents and local implementation of our partner’s and its client’s Patient Safety objectives, policies, procedures and processes
  • To maintain up to date knowledge of the client products assigned with focus on the safety perspective. This includes but is not limited to pharmacology, indications, safety and efficacy aspects and could potentially include clinical studies and epidemiological analyses
  • To review client safety surveillance plan and changes made in it, if any
  • To review aggregate case reports from client designated safety database & other sources as applicable, using relevant client designated safety surveillance tool
  • To conduct initial evaluation of safety signals from routine review of cumulative safety data and document outcome according to client specified criteria and requirements
  • To document potential signal and related information as per client specified criteria & requirements and maintain surveillance action log up to date
  • To notify client surveillance team of any safety signal that it has detected that may require urgent evaluation and action
  • To conduct further evaluation of safety signal as required by client, if applicable
  • To prepare, summarize, evaluate and document routine pre-SIRC (Safety Information Review Committee) safety outputs, if applicable
  • To participate in routine and ad-hoc team and project related meetings between client and our partner like Handover Meeting, Surveillance Meeting, and Safety Strategy & Management Team Meeting, as applicable
  • To prepare training material, conduct and assess periodic and need based trainings as and when required
  • To provide ongoing training on the updated SSP, routine signal management requirements, product safety profiles and updated safety signal evaluation criteria for new hires
  • To participate in conducting gap analysis, and identify the remedial actions for the improvement of quality of deliverables as and when required
  • To provide regular work update to Team lead-safety surveillance


Requirements:

  • Medical degree (MBBS or equivalent and above) with more than 1 year of Pharmacovigilance experience in Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities
  • Experience in diverse therapeutic areas is preferable
  • Knowledge of drug safety & clinical development and ICH/GCP principles
  • Good knowledge of pharmacovigilance practices, particularly in relation to signal detection and evaluation
  • Good knowledge of global Pharmacovigilance regulatory requirements
  • Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions with client
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
  • Good problem solving and decision making skills
  • Knowledge of US and EU pharmacovigilance regulatory requirements
  • Sound understanding of the Drug Safety and Regulatory process


What our partner offers:

  • Opportunity to work from home with flexible hours in full-time or part-time
  • Multicultural team and environment
  • Opportunity to work with one of the Top 10 Pharma company partners
  • Excellent compensation package

Jelentkezem az állásra

Jelentkezési lap

    Önéletrajz feltöltése

    Fájl feltöltése

    Microsoft Word vagy PDF (5MB)

    or