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Innovation
Consulting

Case Management Specialist 341

ProductLife Group is looking for a Vigilance professional to join our dynamic teams ASAP for an exiting project for one of our top clients.

About us

Group 10
Responsibilities

  • Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
  • Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
  • Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
  • Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
  • Data entry for complex cases (seek support from senior specialist as applicable)
  • Performing follow-up for requesting additional information from multiple sources.
  • Assist in the quality review of data captured in the GIRS as applicable
  • Verify and ensure translation of safety information, if applicable.
  • Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
  • Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
  • Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).

Group 11
Education

  • A degree in life, health or pharmaceutical sciences is preferred.

Group 12
Experience

  • Similar experience of 1-3 years

Group 13
Skills

  • Proficiency in Medical terminology (local languages).
  • Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
  • Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
  • Ability to prioritize and work to strict timelines daily
  • Excellent verbal and written communication skills in English and French languages is required
  • Ability to negotiate and communicate with internal and external customers
  • Knowledge and understanding of key legislation applicable to pharmacovigilance within

Case Management Specialist 341

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