My client who is a leading life sciences company based in Athlone are currently looking for a QPPV Associate to join them on an initial 8 month contract.
Role: QPPV Associate
Location: Athlone, remote work available, for first week or 2 of contract would need to be based onsite either in Dublin OR Athlone
Contract: 6- 8 month hourly rate contract
Days: 2 days per week, 16 hours per week, remote work
My client have an excellent reputation in the market and are one of the leading distributors of medical, laboratory and pharmaceutical products in Ireland and UK. Their business model is focused completely on the enhancement of patient care and improving the lives of patients. They deliver cost effective, high quality medicines, devices and diagnostic products across a vast range of therapy areas.
They are currently looking for an experienced Qualified Person PV Associate to join them on an initial contract with a start date in mid-January.
The role can be based remotely or on-site depending on the candidates preference, it would be a 2 day week covering 16 hours a week.
Your role will be to provide oversight of the marketing authorisation holder's pharmacovigilance system providing feedback and guidance to ensure compliance with Good Pharmacovigilance Practices. As the Qualifed Person PV you will have an overview of medicinal product safety profiles and any emerging safety concerns for a portfolio of approx. 40-60 molecules.
You will also oversee conduct of pharmacovigilance and submission of all pharmacovigilance related documents in accordance with the legal requirements and GVP. You will also oversee the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency. Your role will also involve providing input into the preparation of regulatory action in response to emerging safety concerns (eg variations, urgent safety restrictions, and communication to patients and healthcare
- Support on the update and maintenance of the company's Pharmacovigilance systems in line Good Pharmacovigilance Practice
- Oversee and review content of the Post Marketing Review Meeting (Signal Detection) ensuring supporting information preparation is completed in a timely manner
- Review and approve PSUR's prior to Competent Authority submission - there will be 2 during this 6- 8 month period
- Review of Risk Management Plans and risk minimisation activities, possibly up to 6 for renewals and ad hoc basis for new product applications approx. 3)
- Review and approve ADCO's - possibly approximately 6
- Provide Pharmacovigilance support and advice to the PV team
- 2 Hours/week on PV team meetings
- Oversight of weekly literature search (1-2hr per week)
- Review of new Partners and Products (anticipate 2-3 products)
- Audit scheduling and auditing partners
- Impact assess company change controls and approve pharmacovigilance change controls to be brought to CRB
- Review, approve and update pharmacovigilance agreements with all partners approx. 15 renewals and 5 new agreements per year
- Monitor pharmacovigilance compliance (KPI) - including XEVMPD, ICSR reporting timelines, PSUR reporting timelines)
- Attend Management meetings 2 hrs per moth
- Review all reportable cases 3-5 per month prior to submission
- Review ongoing maintenance and update to the PSMF (updates made on a quarterly basis
- Ensure compliance with pertinent GVP, GCP, GMP, ICH, international, and local regulations
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