Pharmacovigilance Officer in Veterinary Medicines

6 maanden geleden

Amsterdam Zuid, Nederland European Medicines Agency Voltijd

**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

**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.- 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.- 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, manufa

  • Trainee (Translational sciences: Implementing the '3Rs' in medicines development and regulation)

    4 maanden geleden

    Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee (Translational sciences: Implementing the '3Rs' in medicines development and regulation) Type of position: Trainee Job Type: 30 September 2024 23:59 CET Selection procedure reference : EMA/TR/10671  Deadline for applications : 30 September 2024 23:59 CET  The European Medicines Agency (EMA) is a decentralised agency of the European...

  • Leading Expert in Immersive Technologies for Regulatory Science

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland The European Medicines Agency (EMA) Voltijd

    About the European Medicines AgencyThe European Medicines Agency (EMA) is a leading regulatory authority in the field of human and veterinary medicines. Our mission is to protect and promote public and animal health through the evaluation and supervision of medicines.Job Title: Leading Expert in Immersive Technologies for Regulatory ScienceWe are seeking a...

  • Business Analyst, Amsterdam

    4 weken geleden

    amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Business Analyst in the office of Veterinary Medicines Information Management responsible for:Contribution to safeguarding public and animal health across the EU and EEA....

  • IT Program Manager/ Customer Portfolio Lead

    6 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Job grade**: AD06 **Interagency/Internal job grade**: AD06 and above **Type of position**: Temporary agent **Selection procedure reference**: EMA/AD/10461 **Job title**: IT Program Manager/ Customer Portfolio Lead **Sub-family**:Customer Portfolio Relationship Management **Monthly Salary: 6,661.12 Euro **(including local weighting) [1]** **plus**...

  • Trainee (Monitoring of antimicrobial consumption and resistance)

    4 maanden geleden

    Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee (Monitoring of antimicrobial consumption and resistance) Type of position: Trainee Job Type: 30 September 2024 23:59 CET Selection procedure reference : EMA/TR/10679  Deadline for applications : 30 September 2024 23:59 CET  The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam....

  • Data Protection and Data Governance Officer

    3 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Job grade**: FGIV **Internal job grade**: **Type of position**: Contract agent **Selection procedure reference**: EMA/CA/10647 **Job title**: Data Protection and Data Governance Officer **Talent Pool**:FGIV Compliance & Legal (Corporate Functions & Administration) **Monthly Salary: 3859,66 Euro **(including local weighting) [1]** **plus** benefits...

  • Project/Programme Officer, Amsterdam

    4 weken geleden

    amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Project/Programme Officer in the office of Case Management & Data Integration responsible for: Planning and execution of work in the assigned Platform, composed of a portfolio of applicat...

  • Project/Programme Officer, Amsterdam

    1 maand geleden

    amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Project/Programme Officer in the office of Case Management & Data Integrationresponsible for: Planning and execution of work in the assigned Platform, composed of a portfolio of applicat...

  • Communication Officer, Amsterdam

    2 weken geleden

    Amsterdam, Noord-Holland, Noord-Holland, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Communication officer in the Communication Department responsible for:implementation of communication strategies and creation of compelling and engaging content that reinforces the reputation of the Agen

  • Adecco | Communication Officer, Amsterdam | amsterdam

    2 weken geleden

    amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Communication officer in the Communication Department responsible for:implementation of communication strategies and creation of compelling and engaging content that reinforces the reputation of the Agen...

  • Adecco | Communication Officer, Amsterdam | amsterdam

    3 weken geleden

    amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Communication officer in the office of Online Communication Service responsible for:writing, editing, publishing and maintaining content on EMA's corporate website, , and for designing and delivering fea...

  • Communication Officer, Amsterdam

    3 weken geleden

    Amsterdam, Noord-Holland, Noord-Holland, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Communication officer in the office of Online Communication Service responsible for:writing, editing, publishing and maintaining content on EMA's corporate website, , and for designing and delivering fea

  • Trainee (Monitoring of Antimicrobial Consumption and Resistance)

    2 maanden geleden

    Amsterdam, Noord-Holland, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee (Monitoring of Antimicrobial Consumption and Resistance)The European Medicines Agency (EMA) is seeking a motivated and qualified trainee to join its Veterinary Antimicrobial Monitoring and Resistance Service. As a trainee, you will support the collection and reporting of data on the sales and use of antimicrobials in animals under Regulation (EU)...

  • Procurement and Contract Management Officer

    3 weken geleden

    Amsterdam, Nederland European Medicines Agency Voltijd

    **Job grade**: FGIV **Internal job grade**: **Type of position**: Contract agent **Selection procedure reference**: EMA/CA/10744 **Job title**: Procurement and Contract Management Officer **Talent Pool**:Planning, Commercial Operation, Finance & Accounting **Salary**:3859,66** Euro **(including local weighting) [1]** **plus** benefits** **Location**:...

  • Trainee (Data Management)

    4 maanden geleden

    Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee (Data Management) Type of position: Trainee Job Type: 30 September 2024 23:59 CET Selection procedure reference : EMA/TR/10673  Deadline for applications : 30 September 2024 23:59 CET  The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is...

  • Data Scientist Trainee in Digital Business Transformation

    1 maand geleden

    Amsterdam, Noord-Holland, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee Role in Data Science and AnalyticsThe European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.As a Trainee in Data Science and Analytics, you will be part of the Analytics Centre of...

  • Trainee (Data Scientist in the Analytics Centre of Excellence)

    4 maanden geleden

    Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

    Trainee (Data Scientist in the Analytics Centre of Excellence) Type of position: Trainee Job Type: 30 September 2024 23:59 CET Selection procedure reference : EMA/TR/10681  Deadline for applications : 30 September 2024 23:59 CET  The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam....

  • Communication Officer, Amsterdam

    3 weken geleden

    Amsterdam, Nederland Adecco Voltijd

    For the European Medicines Agency we are looking for a Communication officer in the office of Online Communication Service responsible for:writing, editing, publishing and maintaining content on EMA's corporate website, www.ema.europa.eu, and for designing and delivering features to improve the website's user experience (UX). Bringing your...

  • [netherlands] Supervisor, Safety Vigilance

    3 maanden geleden

    Amsterdam, Nederland Santen Voltijd

    **Company Description** Santen **is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for...

  • Procurement and Contract Management Specialist

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland Adecco Nederland Voltijd

    We are seeking a highly skilled Procurement and Contract Management Assistant to join our team at the European Medicines Agency in Amsterdam, Netherlands. As a member of the CIO office, you will play a crucial role in implementing the Agency's annual work plan and extended mandate.Key ResponsibilitiesProvide support with the implementation of low-value...