Posted on Oct 1, 2021 by Real Staffing Group
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its infused medicines, rare diseases and inflammation groups. global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.
The Pharmacovigilance Specialist will support the Pharmacovigilance Alliance Management and EU QPPV team in Global Headquarters in Dublin.
The team is responsible for the drafting, negotiating and oversight of Pharmacovigilance Agreements with our Business Partners and Vendors. The team are also overseeing the production of the Pharmacovigilance System Master file. This position will report into the Director., Pharmacovigilance and will play a key role in ensuring the company have contracts and PV provisions in place with our Business Partners and Vendors as well as ensuring we are compliant with our obligations set out in agreements.
- Preparing training materials and delivering PV training to PV vendors
- Supporting the EU QPPV Office and in particular the PSMF maintenance and oversight of the local QPPV network and activities.
- Tracking and oversight of Business Partners and Vendors
- Tracking and oversight of PV obligations in Pharmacovigilance agreements
- Reviewing vendor contracts for inclusion of PV provision
- Taking minutes during team meetings and meeting with Business Partners and vendors
- Drafting and negotiating amendments and terminations
- General administrative support to the PV alliance and EU QPPV office team
Qualifications and Skills Required
- Science degree
- Knowledge of pharmacovigilance regulations
- Minimum of 2 years of experience in the pharmaceutical industry
For immediate consideration apply with an up to date CV. Not sure yet? No CV ready please get in touch for more information?
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales