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.

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).

Education

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

Experience

  • Similar experience of 1-3 years

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

Publish Date

09 November, 2021

Spontaneous Application

Case Management Specialist 341

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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