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My client which supplies both Medical Device & Pharmaceutical Products to the UK and Irish Market has a requirement for a Pharmacovigilance Specialists.
- Senior Pharmacovigilance Specialist / 12 Month Maternity Leave Contract
Reporting to the QP/PV Manager this positions is based at their Midlands Facility and is open to Candidates with 2 Years or more in Quality, Compliance, Regulatory Affairs or Pharmacovigilance Experience in the Pharmaceutical Sector.
Negotiable packages dependent on your level of experience, get in contact today or send me your CV – APPLY TODAY
Pharmacovigilance / Associate Pharmacovigilance / PV Specialist / Compliance / Regulatory Affairs / Pharmaceutical / Pharmaceutical / Athlone / West Meath / Roscommon / Ireland
Job Title: Pharmacovigilance Specialist
- 1 x Full Time / 12 Month Mat. Leave Contract
- € – Dependent on Experience and open to Negotiation
- Paid Annual Leave
- Educational Assistance
- Evaluate adverse event reports received directly from regulatory authorities and input relevant reports onto an internal database
- Process safety data arising from all source as per SOPs
- Report safety data using EudraVigilance
- Input into extended EudraVigilance Medicinal Product Dictionary
- Prepare and participate in regular signal detection meetings
- Prepare and ensure submission of PSURs and Risk Management Plans in a timely manner
- Update Pharmacovigilance System Master File as required
- Ensure identified safety variations are planned, tracked and sent as per set timelines in accordance with the legislation
- Respond to medical information queries
- Respond to queries form regulatory authorities
- Review product information, prepare Addendum to Clinical Overview as required
- Liaise with the Regulatory Department to ensure label updates arising from Pharmacovigilance activities are implemented in a timely fashion
- Prepare weekly reports for the Regulatory Manager and QPPV
- Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012 and directive 2010/84/EU as applicable, and also the company procedures
- Participate and assist in the training of Pharmacovigilance personnel
- Attend external meetings/training courses to maintain/improve overall knowledge of Pharmacovigilance procedures, guidelines and directives
- Third Level Qualification / Degree
- 2 Years Plus Quality, Compliance, Regulatory Affairs or Pharmacovigilance Experience in the Pharmaceutical or Medical Device Sector
If you would like to be considered for this opportunity why not contact me directly on my mobile 00353 (0) 87 25 35 247; Just ask for Patrick.
Alternatively, follow the links below and send me your CV.
Key Words: Pharmacovigilance / Associate Pharmacovigilance / PV Specialist / Compliance / Regulatory Affairs / Pharmaceutical / Pharmaceutical / Athlone / West Meath / Roscommon / Ireland
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