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Pharmacovigilance Scientist

Pharmacovigilance Scientist

(Permanent - Full time - Dublin)

As a Pharmacovigilance Scientist you will play a vital role within the Pharmacovigilance function being responsible for providing support for various operations, in particular, the medical and scientific functions regarding safety evaluations of all products.

Responsibilities:

  • Monitoring the weekly literature, responding to Requests for Further Information from Regulatory Authorities
  • Compiling periodic and addendum safety reports and Risk Management Plans
  • Review and advise regarding relevant local and global guidelines, policies, internal procedures and SOPs across affiliate companies
  • Manage outsourced data collection, organisation and preparation with vendors as required
  • Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports etc.) responsible for oversight and coordination of tasks related to that area
  • Preparation of ad-hoc and scheduled aggregate safety reports
  • Ensure Good Documentation Practice
  • Maintain awareness of Pharmacovigilance regulatory requirements and developments
  • Direct interaction with Regulatory Authorities
  • Write clinical documents for submission to regulatory authorities, to include, clinical overviews and summaries, integrated summaries of safety and efficacy, Clinical Expert Statements
  • Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution and ensure all document contents and styles adheres to FDA/EMA or other appropriate regulatory guidelines as well as complies with the company SOPs and style guidelines
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Review worldwide literature for designated products and identify safety issues/ ICSRs in a timely manner
  • Signal Management Activities including compilation of Signal Assessment Reports/ Case Series Reviews for potential signals
  • Creation and update of Safety Data Exchange Agreements (SDEAs)

Requirements:

  • Third Level Degree in Science or a relevant discipline
  • Minimum of 2 years' experience in the Pharmaceutical industry with knowledge of Pharmacovigilance Regulations
  • Knowledge and experience of writing large safety reports as DSURs, PSURs, RMPs, etc
  • Familiarity with Safety Databases and MedDRA coding dictionary

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.

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