11 months ago
(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.
- 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)
- 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
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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