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Pharmacovigilance Specialist, Munster
| Salary(€): |
0 - 0 |
| Location: |
Munster |
| Ref: |
103802 |
Pharmacovigilance Specialist, Munster
Required to fulfill the role of Qualified Person ensuring Drug Safety, as per Pharmacovigilance requirements in both Ireland and EU, for our client based in Munster.
Ideal candidate will build and maintains strong relationships with the IMB and other competent authorities.
Responsibilities of Pharmacovigilance Specialist:
Authority on the Pharmacovigilance framework in Ireland and Europe.
Ensure medical review and approval of medicinal product advertising & promotional materials.
Develop and implement Risk Management Plans for products.
Provide advice and support on Medical enquiries and other medical aspects relevant to the business.
Collate, process, code, classify medical review and report ICSRs.
Register with Eudravigilance and Electronic reporting of ICSR’s via EVWEB
Assess adverse reactions for potential signals
Produce summary safety tables for review
Review / writing of Periodic Safety Update Reports and searching for ADRs
Review SOP’s and creation of new SOP’s as appropriate for the business
Support EU Pharmacovigilance initiatives and issues as appropriate.
Prepare and train of all relevant personnel for Regulatory Inspections.
Requirements of Pharmacovigilance Specialist:
BSc Degree or Pharmacy primary degree.
4+ years’ experience in Pharmacovigilance in the Pharmaceutical Industry.
Strong commercial awareness, to assess the commercial implications of decisions and advice.
Rounded knowledge of the national and EU regulatory framework.
Solid interpersonal, communication and organisational skills required.
Ability to work independently with minimal supervision.
Confident public speaker and proficient in preparing and delivering presentations.
Please phone Larry on 01 - 2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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