Pharmacovigilance Officer in Veterinary Medicines
Job grade: FGIV
Internal job grade:
Type of position: Contract agent
Selection procedure reference: EMA/CA/10436
Job title: Pharmacovigilance Officer in Veterinary Medicines
Sub-family: Safety and Risk Management
Deadline for applications: 15 May 2024 at 23:59 CET
Salary: 3982.82 Euro (including local weighting) [1] plus benefits (see calculators on the right)
XX
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.
Selection procedure timelines
Deadline for applications |
15 May 2024 23:59 CET |
Preliminary Assessments |
Week starting 3 June 2024 |
Final assessments |
Week starting 17 June 2024 |
Decision expected |
By end of June 2024 |
Selection process
Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.
Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.
Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family, grade specific competencies, role competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.
Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.
Shortlisting
In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria and sub-family competences.
The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.
To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.
Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.
Assessments
Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.
Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above).
Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.
Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.
Reserve list and/or job offers
The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.
We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.
When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.
More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.
Conditions of employment
In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.
The successful candidate will be required to relocate to the Netherlands to take up duties.
[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 114.6. Please consult the Eurostat and Commission websites for more information on weightings.
______________________________________________________________________________________________________
Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands
Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu
© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
Job Segment:
Veterinarian, Compliance, Data Mining, Risk Management, Law, Veterinary, Legal, Finance, Technology