Pharmacovigilance Services

We offer a complete and comprehensive pharmacovigilance service to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). Our pharmacovigilance consultants have significant experience in working with companies all over the world.

As a company that works with a global client base, we handle a wide range of pharmacovigilance related issues for client companies.  Some of the most frequently requested services that we offer are detailed below.  If we can assist you, then please get in touch with us.

Do you require a Qualified Person for Pharmacovigilance (QPPV)?

We can help you fulfil this requirement, offering round the clock availability of a Qualified Person for Pharmacovigilance (QPPV) services. Our dedicated Pharmacovigilance team are ready to act as your QPPV or deputy QPPV and manage the ongoing safety evaluation of your products, which is flexible to suit your budget.

Electronic Reporting & Eudravigilance

We have established procedures for the collection, management and medical evaluation of all case safety reports, including product complaints and medical information queries. We ensure 100% compliance with reporting timelines in relation to the reporting of adverse reactions as individual case safety reports (ICSR) to Eudravigilance and the Competent Authorities while keeping you informed.

Signal Detection

Through the expertise of our pharmacovigilance team and medical experts, our signal management process covers all activities from signal detection and analysis to signal assessment and recommending action where appropriate.

PV Auditing

Our experienced team of pharmacovigilance auditors can address the specific demands of the PV legislation by conducting risk based systems audits of the PV system, 3rd party service providers and distributors. We offer very competitive rates for PV auditing, contact us today for a quote.

Pharmacovigilance Training

MAHs in Europe must ensure that all personnel involved in the performance of pharmacovigilance activities receive initial and continued training. Training plans and records must be maintained for documenting and developing the competencies of personnel. Our team of experts can provide pharmacovigilance training face-to-face or via webex, thus ensuring you have the fundamental skills to do your job and avoid audit findings.

Get in touch with us today by calling 00353 52 61 76706 or completing your details below.

Meet the Pharmacovigilance Team
Gemma Robinson PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved in client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance, and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects.
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Yvonne McCormack
Pharmacovigilance Manager
Yvonne is the Pharmacovigilance Manager at Acorn Regulatory. In addition to PV qualifications, Yvonne is a qualified QP and brings that same high level of quality to the PV system at Acorn. In her current role she manages a diverse PV team (which includes QPPV, Medical Assessor and UK National Contact Person) conducting Routine Pharmacovigilance, Contract Management, PSMF management, Signal Detection, Aggregate Reporting, RMP preparation and PV Auditing. A recent project has seen the Acorn Regulatory Pharmacovigilance Team open a UK based office to offer UK Pharmacovigilance services to our clients with UK MA’s, including UK PSMF, preparation, maintenance and submission, and National Contact Person services.
Eileen Shortiss
Senior Regulatory Affairs Advisor -Pharmacovigilance
Eileen Shortiss joined Acorn Regulatory in 2006. During her time with Acorn Regulatory, Eileen has worked on a vast array of projects for clients all over the world. Eileen is extensively involved with pharmacovigilance KPIs and driving continuous improvement measures across the department. Furthermore, she has considerable expertise and experience in the area of patient information leaflets.
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Avril Keane
Regulatory Affairs Advisor - Pharmacovigilance
Avril is a qualified Pharmacist with experience in clinical, community and regulatory settings. Avril’s role encompasses all aspects of the PV function at Acorn Regulatory with specialty in scientific report writing. Avril works closely with the Medical Assessor and QPPV in her preparation and critical assessment of ICSR’s for expedited reporting, signal detection reports and PSUR’s. Avril also prepares RMP’s for Clients to support their submissions to the Regulatory Authorities. Avril has built a strong collaborative relationship with our global Clients and their 3rd Parties though her interactions with them on routine PV and reconciliation.