Qualified Person (QP)

18% bonus

Job Purpose: (briefly summarise the overall purpose of the role) Provide expert knowledge in documentation handling and maintenance to Clinical Development team. Implement processes for ensuring Clinical Development documentation management adhere to regulatory requirements and global guidelines as well as project plans TauRx policies and procedures. Maintain internal study-specific team training tracker and coordinate internal protocol training sessions as needed. Provide project support to the Global Project Lead(s) in all aspects of the study as directed. 1. Support the Global Project Lead(s) in all aspects of study oversight as required. 2. Maintain internal study-specific team training tracker and coordinate internal protocol training sessions as needed. 3. Responsible for providing specialist knowledge and expertise to the Clinical Operations Team on records handling and maintenance of Trial Master Files and Sponsor Oversight Files. 4. Responsible for coordinating and performing regular reviews of Trial Master Files and Sponsor Oversight Files for quality and completeness as per the TMF Plan. Also to assign and communicate actions and follow up on their progress and close-out. 5. Responsible for tracking TMF Reviews to ensure the timelines for review in the TMF Plan are adhered to. 6. Liaise with TauRx Records Management and Global Project Lead to ensure Trial Master File Plans and associated documentation accurately reflect the project requirements. 7. Prepare for Site Visits to ensure accurate and thorough reconciliation with Investigator Site Files and Trial Master Files as required. 8. Responsible for quality review and submission of documentation to Sponsor Oversight Files or Trial Master Files as required. 9. Risk Management: Support the Global Project Lead reviewing and assessing study risks where required as per the study-specific risk management 10. Quality: Support with progression and close-out of study Quality Issues (QIs) / CAPAs as directed by the Global Project Lead. 11. Schedule and coordinate study meetings materials and agendas and distribute decisions actions and minutes as required. 12. Responsible for assisting in the update of SOPs associated documents and project plans and appendices as required. 13. Provide support to the Clinical Safety Specialist and act as back-up when required. Responsibilities when providing back-up in times of absence/leave should include but are not limited to monitoring of the safety mailbox daily ensuring any safety cases are processed correctly as per study plans and procedures and processing safety cases where applicable (study dependent) as per study plans and procedures. 14. Appointed Trusted Deputy for Eudravigilance. 15. Back-up Administrator for Protocol Deviations (PD) submitted to the PD mailbox. 16. Act as back-up for coordinating and tracking study insurance. 17. Comply with the requirements of a TauRx Trial Master File (TMF) including the TauRx Sponsor Oversight File (SOF) per the study-specific TMF plan 18. Conducts all job-related activities according to the TauRx QMS and relevant regulatory and guideline requirements.

MIT: Candidate is a pharmacist - Must speak fluent English and French Open to junior to mid level Very open on salary They are looking directly only at the moment - however open to seeing comparative candidates - said we would send terms with first CV

This position is ideal for a free lancer/part timer and requires only few hours of work every quarter to complile data in govt. software and file reports related to adverse effect or quality issues with products in case they arise. Part time - just a few hours a quarter required apparently Contract basis Needs to be German qualified - QPPV background Medically trained

25% split Ant

We have a Dir Pharmacovigilance Case Mgt. Im going to release to you today. Perm role. Can be based out of Dublin or Uxbridge. Full time remote working is not an option so they must be in the area or willing to relocate. Reports into an Exec Dir Head of PV based in the US Open to salary - will depend on experience Theyll manage a team of circa 7 - based in the US No actual case processing is done in Regeneron its all outsourced so this role is focussed on the vendor relationship side. Vendor mgt experience is essential and previous case processing experience a big plus (so they can pick up on any problems quicker) Its a new role - weve never had a Dir in this before weve a very flat structure and with growth we need to add in more layers