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Pharmacovigilance Lead

Pharmacovigilance Lead

(Permanent - Full time - Dublin)

Responsibilities:

  • Manage the receipt, processing, follow-up and reporting of adverse events and quality complaints to ensure compliance with company procedures and regulations
  • Review and approve Quality agreements and Safety Data Exchange Agreements for PV and product complaints
  • Prepare for audits/inspections as required - Implement a process for regular self-inspection, and maintain audit readiness at all times
  • Manage the QMS for pharmacovigilance and product complaints, to include deviation reporting, trending of errors, corrective and preventative actions
  • Maintain the pharmacovigilance documentation system, to include SOP writing and review, AE reporting forms, work instructions. Develop and maintain pharmacovigilance protocols
  • Establish and monitor Key Performance Indicators (KPIs) for each staff member and ensure that annual reviews take place according to company policies
  • Keep up to date with local and European PV legislation; participate in continuing professional development and education

Requirements:

  • Third Level Degree in Science or a relevant discipline
  • Minimum of 3 years' experience in Pharmacovigilance
  • Proven leadership experience

Interested?

The next step for you:

Should this position be of interest to you please forward your CV to Renata Kormann from Next Generation Recruitment or alternatively call on the main line on +353 1 6629120. Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement & Operations. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. All our calls are recorded for training and monitoring purpose. Please read our Data Protection Policy on our website.