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Job Details

Pharmacovigilance Scientist Permanent

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LCD9923
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Negotiable

Job Summary:

Our client , a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Scientist role. This is a permanent position.


Our client , a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Scientist role. This is a permanent position. 

 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 Group 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 company 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 
•    Contribute to agreed PV Team quality and compliance targets 
•    Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs 
•    Direct interaction with Regulatory Authorities 

•    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 
•    Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review. 
•    Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with company SOPs and style guidelines. 
•    Perform literature searches/reviews as necessary to obtain background information and training for development of documents. 

•    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 
•    Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans 
•    Manage safety related requests from regulatory agencies and company Affiliates to ensure any requests are answered fully and promptly 
•    Review worldwide literature for designated products and identify safety issues/ ICSRs in a timely manner 
•    Coordinate and prepare appropriately for signal management meetings 
•    Signal Management Activities including compilation of Signal Assessment Reports/ Case Series Reviews for potential signals 
•    Creation and update of Safety Data Exchange Agreements (SDEAs) 

•    Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials as requested 
•    Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities 
•    Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature 

•    Maintain rigorous adherence to written procedures, e.g. SOPs/WINs 
•    Adherence to Company Health & Safety procedures 
•    Participate in training programmes 
•    Any other duties as assigned by your Manager 


•    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 
•    Excellent attention to detail 
•    Excellent written and oral communication skills 
•    Understanding of the principles of information storage and retrieval and skill in their application 
•    Awareness of competitor products and activity. Excellent interpersonal and communications skills. 
•    A solutions provider with strong multi-tasking abilities 
•    Manage evolving deadlines effectively with regular feedback and updates. 
•    Enthusiasm and drive to take ownership and drive process initiatives. 
•    Occasional travel may form part of the job 

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

Apply for this job: Pharmacovigilance Scientist Permanent

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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