Pharmacovigilance Officer

About this position:

We are seeking talented individuals to provide scientific, regulatory and procedural know-how to support the work of the Human Medicines Division of the European Medicines Agency.
The Human Medicines Division oversees and manages human medicines throughout their lifecycle, from evidence generation planning, through evaluation and monitoring of medicines to interfacing with stakeholders to facilitate access and optimal use. The division also supports the European regulatory network to produce patient-centred high-quality scientific opinions.  
As Pharmacovigilance Officer in the Human Medicines Division, you will contribute to the promotion and protection of public health in the European Union and the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. You will also support the development of innovative medicines that make a difference for patients. In this role you will be supporting EMA’s scientific committees and expert groups and cooperate with highly qualified professionals from 30 EU and EEA countries.

As Pharmacovigilance Officer in the Human Medicines Division, in close collaboration with the various functions of the division and across the EMA, you will:

• Perform EMA signal detection activities:  

- Review the electronic Reaction Monitoring Reports for identification of potential safety signals 
- Review EudraVigilance line listings and individual case reports when appropriate and to perform further data analysis where necessary 
- Review literature articles and alerts for identification of potential safety signals 
- Review safety issues communicated by other regulatory authorities in the framework of existing confidentiality agreements 
- Perform signal validation activities, including preparation of clear signal descriptions of issues identified 

• Provide scientific coordination and regulatory and/or procedural support on signal management to the EMA’s Scientific Committees, Working Parties and other expert groups; 
• Support the product team for pharmacovigilance issues;  
• Provide scientific support relating to safety communications;  
• Address requests related to access to information/documents from EudraVigilance; 
• Conduct ad hoc queries and related data analyses based on requests from (Co)-Rapporteurs, EMA’s Scientific Committees and relevant Working Parties in the context of product related safety issues using EVDAS;
• Perform specific scientific projects in the area of pharmacovigilance and signal detection; 
• Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal detection;  
• Lead development of regulatory and scientific guidance documents and provide training as required; Contribute to knowledge management on pharmacovigilance matters;
• You may also be asked to spend time supporting activities of the Inspections Office the area of pharmacovigilance. Activities would include selection and coordination of GVP inspections, related to human or veterinary medicines submitted/authorised through the centralised procedure, including scientific/regulatory and procedural support, and supporting actvities related to the PV Inspectors’ Working Group.
   

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

Apply if you meet these eligibility requirements:

General Conditions: 

1.    Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2.    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-Sciences (e.g. pharmacy, medicine, biology, chemistry, biochemistry) that must have been obtained by the closing date of this vacancy notice;

General Condition 1 and Specific Conditions 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 scientific, regulatory, or procedural aspects of the research, development, authorisation, production or monitoring of human medicines, obtained in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting.
 
In particular: 

• At least 2-year professional experience gained in a regulatory authority or in the pharmaceutical industry as pharmacovigilance specialist or GVP inspector or involvement in PV QA/audit activities or in the detection of safety signals.

Skills and Knowledge

• Good knowledge of the EU pharmaceutical legislation and procedures underpinning the development, evaluation, and surveillance of medicinal products for human use;
• Skills or 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;
• Stakeholder management;
• Critical interpretation and analysis of safety data related to medicinal products use and their outcomes on patients;
• Understanding of European Pharmacovigilance regulations and related good vigilance practice (GVP);
• Knowledge of epidemiology/pharmacoepidemiology. 
   

Competencies you will 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

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered nice to have:

Education

Masters in the field of Life-Sciences (e.g. pharmacy, medicine, biology, chemistry, biochemistry).

Experience

In the preparation or assessment of safety reviews and documents (e.g. signals, PSURs, 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 PV inspections/audit activities and methodology and PV quality management systems.