Overview

The Company

Biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.

The company has a portfolio of medicines through its orphan and inflammation groups. The company’s global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.

The Position

The Senior Manager PSPV Alliance Management & EU QPPV Office is expected to demonstrate in-depth knowledge and expertise in pharmacovigilance and to effectively interface with all relevant departments and personnel, business partners and vendors, and as needed, with the regulatory authorities world-wide.

This position will report into the Associate Director, PSPV Alliance Management & EU QPPV office and will play a key role in ensuring the company have contracts and PV provisions in place with our Business Partners and Vendors as well as ensuring we are compliant with our obligations set out in agreements.

This position will also assist the EU-Qualified Person Responsible for Pharmacovigilance (QPPV) and Deputy QPPV in ensuring the Marketing Authorization (MA) Holder is compliant with the pharmacovigilance requirements in Europe and will also be involved in the co-ordination and organization of a network of Local QPPVs in a number of countries as Horizon expands globally.

Responsibilities include:

*Oversight, drafting and maintenance of PV agreements (PVAs)
*Vendor training on adverse event reporting
*Review of vendor contracts for PV language in contract management system
*Ability to provide hands-on contributions to cross-functional project teams and delivering on schedule
*Provide a pro-active approach to initiatives within the pharmacovigilance /drug safety department and in cross-functional efforts
*Evaluate and implement new technologies and processes
*Share knowledge of all relevant regulatory guidance and standards (e.g. FDA, ICH and EMEA PMDA)
*Provide a pro-active approach to initiatives within the pharmacovigilance /drug safety department and in cross-functional efforts
*Maintenance of the PSMF, management of the overview of PSMF stakeholders and training of stakeholders
*Oversight of maintenance of Article 57/XEVMPD data
*Oversight of management of EU LQPPV network

Qualifications and Skills Required:

*Bachelor’s degree or equivalent (health professional degree preferred)
*5+ years experience in a pharmacovigilance setting within the Pharmaceutical/Biotechnology industry
*Thorough knowledge of GCP and FDA ICH guidelines and the initiative to be at forefront of updates or changes in such guidance
*Ability to evaluate and mitigate risks, navigate challenging situations and present problem solving options.

If you are interested in the role please apply ASAP with an up to date CV. Not sure yet? No CV ready? Get in touch for more information.

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales 

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Compliance Managers