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 experts have significant experience of 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.  However, if our pharmacovigilance team, headed by Natasha Daly, 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
Natasha Daly
Pharmacovigilance Manager
Natasha joined Acorn Regulatory in October 2018 as Pharmacovigilance Manager. Natasha has over 11 years’ experience in the pharmaceutical industry. Her experience comes from working in a large global innovator pharmaceutical company and a large global generic company and includes drug development, post-marketing and clinical trials. Natasha`s role as pharmacovigilance manager at Acorn Regulatory is intended to ensure that the procedures in place are adhered to and that Acorn Regulatory provides a quality of service to its clients acceptable to any inspecting authority.
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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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Geraldine Luciano
Pharmacovigilance Advisor
Geraldine has worked in community pharmacy and has seen firsthand the impact of drugs on public health. Geraldine is responsible for managing client activities daily across myriad of duties including Eudravigilance screening, local/global literature review, ICSR processing & reporting, signal detection activities and the collection of regulatory intelligence.
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