On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Scientist. This is a permanent, full-time role.
The PV Scientist provides support for various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Group products across Affiliate companies for which marketing authorisations are held.
The PV Scientist is largely responsible for coordinating and management of review and analysis of aggregate safety data concerning the product portfolio.
Tasks may include but are not limited to monitoring the weekly literature, responding to Requests for Further Information from Regulatory Agencies, compiling periodic and addendum safety reports and Risk Management Plans, collating data for ad hoc requests, engaging in signal management activities, updating Product Information in line with the Company Core Data Sheets, and other tasks as designated.
The PV Scientist is also responsible for providing leadership, training and support to junior pharmacovigilance staff.
• Delegated tasks from QPPV/ Deputy QPPV/ Senior PV Scientist on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
• 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
• Identification of project challenges to departmental line management and the financial impact thereof.
Medical Writing Accountabilities:
• Write clinical documents for submission to regulatory authorities, including but not limited to:
clinical overviews and summaries
integrated summaries of safety and efficacy
Clinical Expert Statements
• Creation and update of SOPs/WINs for all pharmacovigilance activities related to the job role in line with worldwide Pharmacovigilance and EU regulations/guidelines
• Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports
• Biological/life Sciences Degree or equivalent
• Documented experience in all aspects of pharmacovigilance
• Experience working with safety databases
• Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs, RMPs is desirable
• Experience working with MedDRA coding dictionary
• Pharmacovigilance practice and procedure
• EU Competent Authorities and Regulations
• Marketing Authorisation rules and regulations
• Knowledge of principles of epidemiology and statistics
• Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
• Good documentation practice
• Knowledge and information sharing
If you are interested in applying for this role please call Linda on +353 1 2784671 or email email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com