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Job Details

Pharmacovigilance Specialist

Company: Thornshaw Recruitment
Location: Dublin, Republic of Ireland
Reference: LD9948
Closing Date: 23 Feb 19
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

On behalf of our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Specialist. 

Requirements:

On behalf of our client, a global pharmaceutical company, are currently recruiting for a Pharmacovigilance Specialist. 


Lead support for the Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all products across Affiliate companies for which marketing authorizations are held. Provide leadership, training and support of junior staff.

Responsibilities

  • Expectation of delegated tasks from QPPV 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 relevant local and global guidelines, policies, Internal Procedures and SOPs across Affiliate companies
  • Case processing including triage, data entry, quality control and assessment of SAE/AE reports (including narrative writing) from clinical trial and post marketing sources onto our global database, in accordance with company SOPs and regulatory requirements.
  • Ensure Good Documentation Practice
  • Maintain awareness of Pharmacovigilance regulatory requirements and developments
  • Contribute to agreed PV Team compliance targets
  • Direct interaction with Regulatory authorities
  • Create and maintain contacts across all Affiliate companies to enable them to gain maximum benefit for the business from Scientific affairs
  • Need to keep abreast of changes and development in PV regulations.
  • Provide training and training material to new PV team members as required
  • Assessment and quality control of work completed by external providers (ADDS).
  • Managing the Safety Reporting Plans in line with the SDEAs.
  • Lead and manage projects including the development of project specific safety reporting procedures and workflows and provide guidance to the team on the procedures 
  • Develop project specific safety database customization and data entry guidelines 
    Safety:
  • Work with line management to ensure that adequate SOPs exist for all safety related Pharmacovigilance activities to be carried out in line with Good PV practices and according to worldwide Pharmacovigilance and EU regulations/requirements, to include activities by independent contractors and other third-party vendors where necessary
  • Data entry/review onto company safety database
  • MedDRA Coding
    Training/ Continuous Improvement
  • Improvise incentives 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
    Any other duties as assigned by your Manager

Requirements
•    Life sciences/ Biological sciences graduate 
•    Relevant scientific work experience desirable
•    Competent with medical terminology
•    Excellent communication abilities and possessing good IT Skills
•    Results and performance driven – deliver results that meet or exceed expectations
•    Sense of urgency – responding to issues and opportunities in a timely manner 
•    Intellectual curiosity – willing to suggest and try new ideas
•    Positive and pro-active approach to business tasks
•    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.

If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com
#THR2018

Apply for this job: Pharmacovigilance Specialist

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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