On behalf of our client, we are currently recruiting for a Pharmacovigilance Officer for a part-time role of approximately ***** hours per week.
This will be an ongoing contract.
This position can be remote, hybrid or office based, depending on the preference of the candidate; however, the candidate must be based in Ireland.
Role Overview
Reporting jointly to the Qualified Person for Pharmacovigilance (QPPV) and the CEO (or their delegate), the Pharmacovigilance Officer will join the pharmacovigilance team and will be responsible for the day-to-day maintenance and documentation of ongoing compliance of the pharmacovigilance system and related administrative duties.
Roles & Responsibilities
Under the oversight of the QPPV, the Pharmacovigilance Officer will carry out the following responsibilities and duties with and along with the assistance of contract service providers supported by service level agreements in the following areas:
Maintain a pharmacovigilance system (cGPV) in accordance with EU and international legislation to handle Adverse Event Reports (AER's), Periodic Reports () with overall responsibility for the processing and reporting of safety information to Regulatory Authorities, Licensees, and Distributors.
Document and process all safety information, ensuring that serious adverse event reports are processed and reported according to ICH/EU guidelines, regulatory requirements, and company SOPs or procedures.
Manage all weekly routine PV activities, monitoring the PV mailbox, literature screening, and ICSR download processes.
Manage all reconciliation activities with partners and tracking of Regulatory intelligence.
Manage the review of safety data.
Ensure timely lifecycle maintenance of PV periodic documents such as PBER's, PSUR's, DSUR'S, Signal, and Annual Summary Reports.
Assist the external company medical doctor/physician in the review and follow-up of safety information.
Design and implement process improvements, including procedural documents (SOPs) with QPPV support to ensure the smooth and successful running of the Pharmacovigilance system.
Review monthly and maintain and update as required the EU and UK Project System Master Files (PSMFs) and periodically review the KH Pharmacovigilance Management Plan (PMP) as required.
Under the guidance of the QPPV, oversee and maintain Safety Data Exchange Agreements with a small number of partners and distributors.
Prepare PV monthly report and organise the PV meetings as per agreed timelines.
Person Profile
The ideal candidate will have at least 1-2 years of PV experience in the pharmaceutical industry and have a life science or pharmacy degree.
Skills & Competences
The successful candidate will possess the following:
Knowledge and understanding of the EU regulatory frameworks for medicinal products.
Knowledge of medical device quality standards would be of distinct advantage.
Knowledge and understanding of the food supplement legislation would be advantageous.
International experience in registrations/variations/significant changes of Medicinal Products.
Proven experience within Regulatory Strategy and its execution.
Good understanding of the content and format of MA registration files (CTD and eCTD) with the ability to prepare high-quality submissions.
Previous experience with the preparation and submission of new MAAs, life cycle maintenance in the EU (national/MRP/DCP), and non-EU markets.
Awareness or knowledge of the EU Guidelines on Good Pharmacovigilance Practices (GVP).
Excellent interpersonal skills.
An excellent level of attention to detail and accuracy.
Proven organisational and planning skills.
Strong verbal and written communication skills.
Enjoy and thrive in a fast-paced environment.
Good interpersonal skills, ability to work with others and independently.
Self-motivated, self-driven, and "can-do" attitude.
Excellent IT skills in word processing, Excel, PDF software such as Adobe, document management.
Proficiency in speaking, comprehending, reading, and writing English is required.
Must hold a valid work permit to work in Ireland.
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