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Deputy Qualified Person for Pharmacovigilance

  Dublin,  Ireland |  Full time

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Posting Date :  2022-07-21

Job Identification :  11056

Department  :  Pharmacovigilance

Reporting to the Qualified Person for Pharmacovigilance (QPPV), the Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) is responsible for assisting and providing back up to the QPPV in the day to day European Pharmacovigilance activities within Bimeda Animal Health Ltd. As a person with Pharmacovigilance experience, flexible to the needs of the business, and the ability to build networks and rapport with internal and external stakeholders. A proactive responsible person with an ability to think independently, assist the QPPV in all matters of Pharmacovigilance including Adverse Event reporting, Signal Management review and reporting, development of Pharmacovigilance procedures and training staff within the company (and external distributers) regarding PV regulations and affairs.

Key Role Specific Requirements:

  • Assist QPPV to manage the Pharmacovigilance  function within Bimeda Animal Health Limited, ensuring the Pharmacovigilance system  is fully compliant to current EU  Legislation 2019/6 and relevant EMA guidelines.
  • Assist in the preparation, tracking and on-time submission of reports to European Medicines Agency (EVVET 3)  of all  Suspected Adverse Events  in animals and/or humans.
  • Preparation and Submission of additional data to European Medicines Agency databases.
  • Assist preparation in the preparation and submission of Signal Management Reviews for Bimeda Animal Health Limited products.
  • Assist in the investigation, preparation and submission of Serious Adverse Events and Periodic Safety Update Reports (PSUR) for submission to Veterinary Medicines Directorate (UK).
  • Liaise and assist internal and external stakeholders (e.g. Quality Assurance, Sales, External Distributors) in the communication and investigation of Pharmacovigilance related matters.
  • Maintain and manage Pharmacovigilance agreements and correspondence in relation to Pharmacovigilance  activities with agencies and distributors.
  • Provide training to Bimeda EU personnel regarding Pharmacovigilance responsibilities.
  • Act as a regulator and partner within the Business in Pharmacovigilance related matters.
  • Investigate any assigned Adverse Events (AEs) related to the use of Bimeda Animal Health Limited products, including on-site farm visits to clients as deemed necessary and appropriate.
  • Ability to support the company in other areas of expertise such as Research & Development and Technical advice.
  • Hands-on approach.
  • Flexible to the needs of business with an ability and willingness to travel (within Ireland and internationally when required) and taking ownership of on-call responsibilities, where assigned.
  • High level communication skills and ability to engage, converse, and gather information to support Adverse Event investigations with satisfactory close out for all parties.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

 

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.
  • 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 Requiements:

Essential:

  • Minimum 3rd level Science degree.
  • Good understanding of Pharmaceutical controlled documentation practices
  • Proficient in the use of MS Office tools
  • Excellent written and spoken English
  • Current Driving Licence and/or ability to travel.

Desirable:    

  • 2-3 years’ experience in Pharmacovigilance / Drug Safety within the pharmaceutical industry.
  • Previous experience in Animal Health companies.
  • Veterinary degree most desirable.
  • EudraVigilance training on electronic reporting desirable.

 

At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.

The job posting is available in an accessible format upon request by contacting the Human Resources Manager.

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