An esteemed pharmaceutical organisation specialising in the development and commercialisation of niche products are seeking an experienced Pharmacovigilance professional to join their Dublin team on an initial 12 month fixed term contract. This person will act as Deputy Qualified Person for Pharmacovigilance (DQPPV).
Reporting into the QPPV, you will work cross-functionally with RA, Quality and Artworks and will liaise with the manufacturing site in the UK.
Your responsibilities will include but are not limited to the following:
- Assist the QPPV in maintaining the Pharmacovigilance (PV) systems in line with the requirements for human and veterinary pharmaceutical products
- Assist the QPPV in maintaining an overview of the safety profiles of the company's medicinal products and any emerging safety concerns
- Respond to requests for information from Competent Authorities relating to the safety profile of company products or PV activities
- Prepare Adverse Drug Reaction (ADR) reports and expedite reports to Competent Authorities when required
- Generating and managing aggregate reports
- Prepare, review and assist in submission of PSURs, Risk Management Plans
- Prepare and maintain Safety Data Exchange Agreements and Technical Agreements
You must possess the following to be considered:
- A BSc or MSc in Science or related
- 5 years' experience in Pharmacovigilance / Drug Safety
- Previous experience within Medical Information desirable
- Ability to work autonomously, effectively and collaboratively
- Eligible to live and work in the EU
- Excellent career and professional development opportunities
- Competitive salary
- Completion bonus
- Flexible working hours and work from home options
To discover more about this opportunity, apply now or contact Sorcha Hayward at HRM on + 353 1 6321866 for a confidential discussion.