SNE/Veterinary Pharmacovigilance Specialist

About this position:

The European Medicines Agency (‘the Agency’) is a decentralised body of the European Union 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. 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.

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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, in this role you will be responsible for the scientific coordination and procedural support in relation to the any of 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 e.g. 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 e.g. 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. 
   

Apply if you meet these eligibility requirements:

• You are 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 (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).

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 (e.g. veterinary medicine, human medicine,  pharmacy, 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 medicines pharmacovigilance acquired through one of the following channels: EU competent authority (regulator), academia, pharmaceutical industry. 

Skills & Knowledge

• In the science and activities related to veterinary signal detection and management, and adverse event collection and reporting;
• Specialist knowledge of the EU legal framework and guidelines for veterinary medicines and pharmacovigilance;
• Stakeholder management e.g. 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 e.g. to CVMP Rapporteurs;
• Knowledge of veterinary pharmacology and physiology.

Nice to have

Education

Field of study:

Veterinary medicine. 

PhD or master's degree in a field related to medicines safety. 

Experience

•  In drafting scientific and/or technical documents (e.g. assessment reports, scientific meeting minutes, guidance documents);

Skills & Knowledge

• Understanding of product development and lifecycle management of veterinary medicines e.g. variation procedures;
• Knowledge of veterinary epidemiology/pharmacoepidemiology.
•  Understanding of statistical aspects of signal detection and 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.