SNE/Veterinary Pharmacovigilance Specialist

Type of position: Seconded National Expert

The European Medicines Agency is a decentralized body of the European Union with all its offices and headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines.

We are looking for national experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

About this position

There is currently an opportunity for a Seconded National Expert to work in the Veterinary Division, Surveillance and Regulatory Support Department, Veterinary Pharmacovigilance Office, providing scientific and procedural quality assurance for procedures and topics related to veterinary signal management, and supporting other activities related to pharmacovigilance of veterinary medicinal products.

You will be joining a small, dynamic team who support the CVMP’s pharmacovigilance working party, CVMP Rapporteurs, CMDv and national competent authorities in product-specific pharmacovigilance assessment and in developing guidance. There is the opportunity to interact with industry stakeholders on product-specific matters or for public consultations, as well as providing information to veterinarians and the public on safety outputs of the CVMP.

In this role you will

As Seconded National Expert, you will be responsible for the scientific coordination and procedural support in relation to the following areas:

• Signal management process, including its oversight via the EMA’s regulatory platform IRIS
• Scientific input on pharmacovigilance for veterinary medicinal products in the context of initial marketing authorisation applications and variations, for example content of product information (SPC/package leaflet)
• Contribution to the revision of pharmacovigilance guidance documents (e.g. VGVP modules) and related procedures
• Secretariat support to the CVMP Pharmacovigilance Working Party (PhVWP-V) and its Operational Expert Groups
• Secretariat support for the yearly VeDDRA consultation meeting of the CVMP PhVWP-V
• Scientific/procedural input to National Competent Authorities and to Marketing Authorisation Holders on pharmacovigilance matters, for example supporting targeted signal management procedures, or leading the review of dear animal healthcare professional communications
• Organisation of meetings between EMA, the PhVWP-V and interested parties, including veterinary healthcare professionals
• Exchanges on veterinary pharmacovigilance topics with non-EU regulatory authorities from VICH regions

Eligibility requirements

• You are a national of an EU or EFTA Member State or a candidate country as decided by the Council
• You have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (B2 level)
• You are currently employed in the public sector, such as a university, research institute, public hospital or regulatory body, in a European Union Member State, the European Free Trade Area, candidate countries or public intergovernmental organisations

You will also need to have

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma

Field of study

• Life science, for example veterinary medicine, human medicine, pharmacy or biology

Experience

• At least 3 years from the time when a university degree was awarded on completion of a minimum of three years of study
• Experience in the field of veterinary or human medicines pharmacovigilance acquired through one of the following channels: EU competent authority (regulator), academia, pharmaceutical industry

Skills & Knowledge

• Knowledge of the science and activities related to veterinary or human medicines signal detection and management, and adverse event collection and reporting
• Knowledge of the EU legal framework and guidelines for veterinary medicines and pharmacovigilance
• Stakeholder management, for example coordinating public consultations
• Ability to assimilate and analyse incoming information for arising, fast-moving safety issues on veterinary medicinal products, and to summarise and clearly present that information verbally and in writing, for example to CVMP Rapporteurs
• Basic understanding of veterinary pharmacology and physiology

Nice to have

Experience

• Drafting scientific and/or technical documents, for example assessment reports, scientific meeting minutes, guidance documents

Skills & Knowledge

• Understanding of product development and lifecycle management of veterinary medicines, for example variation procedures
• Knowledge of veterinary epidemiology/pharmacoepidemiology
• Ability to summarise and clearly communicate complex information to both expert and non-expert audiences
• Proactive, positive approach with effective, independent problem-solving skills

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)