Key Role Specific Requirements  

• Assist QPPV to manage the Pharmacovigilance (PV) function within Bimeda EU, ensuring the Pharmacovigilance system is up to current EU Regulation 2019/6, Veterinary Medicines Regulations 2013 (as amended), Good Pharmacovigilance Practice and any other applicable Animal Remedies Legislation/Guidelines. 

• Investigate any assigned Adverse Events (AEs) related to the use of Bimeda products. 

• On-site farm visits to clients, as deemed necessary, in order to converse with end users and gather information to support AEs with satisfactory close out for all parties. 

• Preparation and on-time submission of reports to the relevant Competent Authority of all AEs in animals and/or humans. 

• Prepare Annual statements and signal management reports for submission to the relevant European Competent Authorities and the Veterinary Medicines Directorate (UK) 

• Liaise and assist internal and external stakeholders (e.g. Quality Assurance, Sales, External Distributors) in the communication and investigation of PV related matters. 

• Maintain and manage PV agreements and correspondence in relation to PV activities with agencies and distributors. 

• Provide training to Bimeda EU personnel regarding Pharmacovigilance responsibilities. 

• Act as a regulator and partner within the Business in PV related matters 

• Ability to support the company in other areas of expertise such as Research & Development. 

• Hands-on approach.  

• Flexible to the needs of business with a willingness to travel where required. 

Competencies Required for the Role 

• COGNITIVE FLEXIBILITY – Is the ability to switch from one behavior to another depending on requirements, and reflect on several options to solve problems quickly. 

• CRITICAL THINKING – is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions. 

• FLEXIBILITY/OPENMINDEDNESS-The ability to be open to different and new ways of doing things; willingness to modify one’s preferred way of doing things. Is able to see the merits of perspectives of others than his/her own. 

• JUDGEMENT – is the ability to make considered decisions or come to a sensible conclusion. 

• PROACTIVITY - Is the ability to take the lead on projects; anticipates future tasks and thinks ahead without being told. 

• TEAMWORK – Is the ability to combine forces within a team to achieve a common goal or initiative.              

Other Requirements 

Essential:  

• Minimum 3rd level Science degree. 

• 1 year experience in pharmacovigilance/drug safety within the pharmaceutical/animal health industry. 

• Good understanding of Pharmaceutical controlled documentation practices. 

• Proficient in the use of MS Office tools. 

• Excellent written and spoken English. 

Desirable: 

• 2-3 years’ experience in Regulatory Affairs within the pharmaceutical/animal health industry. 

• Veterinary degree would be of benefit. 

• EudraVigilance training on electronic reporting.