Pharmacovigilance Officer in Veterinary Medicines

About this job:

Working within the EMA’s veterinary pharmacovigilance team to provide scientific input and oversight relating to the detection, assessment, understanding and prevention of safety issues for veterinary medicines in the EU. The role offers the opportunity to regularly interact with committees, stakeholders and partners in the EU regulatory network. You will contribute to developing and operating the respective database systems, developing new data-centric approaches to optimise monitoring of veterinary medicines. 

In this job you will:

• Manage the development and maintenance of good pharmacovigilance practices (GVP) and standards for the system, as well as development and implementation of evidence-based process improvements and updates to GVP;
• Liaise with Market Authorisation Holders (MAHs) with regards to the implementation of signal recommendations of the CVMP's Pharmacovigilance Working Party, including the monitoring of the compliance with signal recommendations, for the update of product information of Centrally Authorised Medicinal Products (CAPs);
• Cooperate with both National Competent Authorities (NCAs) in the management of safety signals for centrally authorised products, and Marketing Authorisation Holders (MAHs);
• Manage risk-management plans and oversight of post-authorisation studies; 
• Drives policies, research and best practices for safety data mining, signal detection planning, management and tracking;
• Monitor safety of CAPs and prepares clear signal descriptions of issues identified.

Here is the link to the Role Description of Scientific Officer outlining generic duties and responsibilities: https://www.ema.europa.eu/en/documents/other/role-description-pharmacovigilance-officer_en.pdf

Apply if you meet those eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:
1.    enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2.    have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3.    have fulfilled any obligations imposed by applicable laws concerning military service.
 

Specific conditions: 
1. Possess a university degree of minimum of three years in Life Science (e.g. Medicine, Veterinary Medicine, Pharmacy, Biology), that must have been obtained by the closing date of this vacancy notice.

General Condition 1 and Specific Condition 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.

Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience

Experience in the regulatory, scientific or procedural aspects of the production and supervision of medicines on the market, with at least 2 years of experience in the science or processes of monitoring the safety of medicines, specifically in the veterinary field.

Skills and Knowledge

• In the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems;
• Good knowledge of the EU pharmaceutical legislation underpinning the development, evaluation and surveillance of veterinary medicinal products;
• Stakeholder interaction and management;
• Critical interpretation and analysis of safety data related to medicinal products' use and their outcomes;
• Understanding of European PhV regulations (GVP) and signal detection theory and/or practice;
• Knowledge of epidemiology/pharmacoepidemiology.

Competencies you will also need to have:

Role competencies    

• Regulatory frameworks & strategy    Basic

Sub-family competencies    

• Pharmacovigilance - Intermediate
• Applied knowledge    Basic

Grade competencies    

• Adaptability and agility    Intermediate
• Coping with pressures and setbacks    Intermediate
• Analysing and problem solving    Intermediate

Core competencies    

• Ethics and integrity    Intermediate
• Team collaboration    Intermediate
• Customer centricity    Intermediate
• Results orientation    Intermediate
• Communication    Intermediate
• Cross-cultural sensitivity    Intermediate
• Continuous learning and self-development  Basic

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered to be nice to have:

Experience

• In information analysis and reporting on scientific/ regulatory matters;
• In drafting scientific and/or technical documents (e.g. peer reviewed scientific publications, reports, scientific meeting minutes, project plans and reports, guidance documents, policies and procedures);
• In the preparation or assessment of safety reviews and documents (e.g. signals, PSURs (under the previous veterinary legislation), RMPs, other regulatory procedures).

Skills & Knowledge

• Understanding of scientific aspects of medicines development (such as quality, manufacturing non-clinical and clinical development, specific aspects of safety); 
• Understanding of signal detection;
• Understanding of veterinary practice, or animal husbandry/production;
• Understanding of working within database systems for data extraction and analysis.

Certificates

• Postgraduate certificate, diploma or MSc in a relevant discipline, e.g. epidemiology, public health, medical statistics, in-data analysis and/or data mining and/or machine learning.