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. 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 (PV) function within Bimeda EU, ensuring the Pharmacovigilance system is up to current EU Regulation 2019/6, 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 Periodic Safety Update Reports (PSUR) for submission to Veterinary Medicines Directorate (UK).
- Prepare Annual statements and signal management reports for submission to the relevant European Competent Authorities.
- 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.
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.
- 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.
- 2-3 years’ experience in Regulatory Affairs within the pharmaceutical/animal health industry.
- Veterinary degree would be of benefit.
- EudraVigilance training on electronic reporting.