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Job Details

Senior Pharmacovigilance Officer / Deputy QPPV

Company: Apex International Recruitment Ltd
Location: South-West England
Reference: 2404SPVOQPPV
Closing Date: 05 Jul 18
Type: Full Time
Salary (£): On Application
Benefits: Competitive salary and benefits available

Job Summary:

Our client have an exciting time ahead with 4 new products being launched this year! As an experienced pharmaceutical professional this is an excellent opportunity for you to develop and broaden your skills through building and maintaining effective working relationships with cross functional and global colleagues. This role offers an exciting opportunity and competitive package in a beautiful location. Relocation assistance possible.

Requirements:

DETAILS:

  • Full-time permanent position
  • Office based in South-West England
  • Competitive package and relocation assistance

 

THE JOB:

The role will involve, and will therefore require, previous relevant experience of the following:

  • Pharmacovigilance System Master File (PSMF): Maintenance of the Pharmacovigilance System and PSMF
  • Quality Management Systems: Maintaining the PV Quality Management System and undertaking associated quality-related activities including Audit, Compliance Monitoring and Quality Improvement.  SOP authoring and management
  • Post-marketing safety data: Processing and reporting spontaneously received post-marketing safety data including its receipt, tracking, coding, assessment and submission to regulatory authorities
  • Safety Data Management: Maintenance of cumulative safety data received from all sources including spontaneous reports, literature sources, National Regulatory Authorities and the EMA
  • Literature review: Review of safety information published in the scientific literature
  • Signal Management: Signal management from signal detection through to assessment and recommendation for action
  • Risk Management and Minimisation: Production, review and maintenance of Risk Management Plans and risk minimisation through effective use of product labelling and (when required) additional materials
  • EudraVigilance: Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information
  • Product labelling: Authoring of safety-related information including updates to product labelling (SmPC, PIL, packaging) and coordination of associated regulatory activities. Supporting new MA applications, lifecycle maintenance and renewal activities.
  • Pharmacovigilance Agreements: Production, review and maintenance of effective Safety Data Exchange Agreements between the company and its business partners

Full details available on application

THE CANDIDATE:

  • The ideal candidate will be an experienced pharmaceutical professional with appropriate and relevant Pharmacovigilance experience and have the ability (if required) to undertake the duties of their colleagues including the QPPV and Deputy.
  • Experience in most of the areas above (if not all) is essential
  • For the right candidate, there is flexibility to the role and responsibilities we can offer.

 

HOW TO APPLY: Interested? – send us your CV now using the Apply button below!!!

However, if this role doesn’t suit your current skill-set, please call Alex on 01227 844466 for further advice.

Only candidates with existing permission to work in the UK / EU can be considered.

About Apex: Apex International is a professional, knowledgeable and niche recruitment agency who recruit across the UK, specialising in  Medical Affairs,  Pharmacovigilance, Regulatory Affairs and Clinical Development (including QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)). For a confidential and professional chat about your job requirements please call Alex on 01227 844466 or email alex@apexrecruitment.com

Our Passion – Your Profession – A consultative approach to recruitment.

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us: www.apexrecruitment.com

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Apply for this job: Senior Pharmacovigilance Officer / Deputy QPPV

Contact Information:

Address:  Apex International
The Blue Room, Kent Enterprise House, 1 The Links, Herne Bay, Kent,
CT6 7GQ
England
Tel:  01227 844466
Fax:  01227 208590
Website:  Visit Our Web Site

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