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Pharmacovigilance Officer

TCP GroupDublinFull-timePermanent

TCP Group is an innovative health services provider specialising in 'direct to' patient and pharmaceutical services on a national scale.

We are looking for a Pharmacovigilance officer who demonstrates a high degree of self-motivation and the ability to adapt to change. 

Role requirements:

  • Degree in life sciences ideal.
  • Drug Safety experience including actual experience processing AE/SAE reports, generating narratives, queries.
  • Previous experience with record management, documentation control, and SOP review.
  • Experience working in a regulated environment.
  • High degree of accuracy with attention to detail. 


Key Responsibilities:

  • To perform triage of the PV mailbox, manage the mailbox, and maintain strong communication with the client.
  • Ensure all activities are completed within the appropriate timeline.
  • Be involved in processing PV events, and product quality complaints in line the organisations operating procedures.
  • Be involved in carrying out regular reconciliation of case reports with internal and external sources.
  • Manage follow up requests and client queries. This will include liaising directly with nursing teams and the patient care bureau to obtain additional information. 
  • Be involved PV quality checks, and source date verification activities where required.
  • Act as a key information resource to pharmacovigilance team for training and other multidisciplinary teams.
  • Maintain the Pharmacovigilance reporting system as well as provide systematic reporting to in-house managers and external clients.
  • Ensure that the PV team are compliant with TCP SOPs, and maintain the Pharmacovigilance reporting system. This will also include assisting in the development of procedures.
  • Represents yourself in a professional and ethical manner at all times and ensuring customer confidentiality at all times.


Beneficial:

  • Familiarity of good pharmacovigilance practices (GVP).
  • Knowledge of medical and drug terminology desirable. 
  • Good written and verbal communication skills. 
  • Ability to work independently with moderate supervision. 
  • Good IT skills, preferably with knowledge of MS office and Windows would be beneficial. 

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