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Pharmacovigilance Manager

Employer
Apex International Recruitment Ltd
Location
South-West England
Salary
Competitive salary and benefits
Start date
3 Oct 2022
Closing date
10 Oct 2022

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Job Details

DETAILS:

  • Full-time permanent position
  • Office based in South-West England
  • Competitive package
  • Global pharma company

 

THE ROLE:

  • NO direct reports /line management
  • 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
  • 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
  • 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 implementation of risk minimisation activities including 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
  • Pharmacovigilance Agreements: Production, review and maintenance of effective Safety Data Exchange Agreements between the company and its business partners.
  • Literature review: Review of safety information published in the scientific literature.
  • 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.
  • Product Maintenance & Development: 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.
  • Medicines Information: Provision of a Medicines Information service - managing resources to deal with medical, pharmaceutical and technical enquiries
  • Full job description available on application

 

THE CANDIDATE:

  • Candidates should have a life science degree in Pharmacy or an additional postgraduate degree would be an advantage
  • A minimum of 8 to 10 years of relevant (post-marketing) EU Pharmacovigilance experience.
  • A clear understanding of the current and developing legislation and the ability to apply this to the company Pharmacovigilance System and processes.
  • Outstanding communication and medical writing skills with exceptional attention to detail - the ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers including business partners and healthcare professionals.
  • Only candidates with existing right to work in the UK/EU will be considered

 

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

Company

Apex are a specialist recruitment agency who supply permanent, contract and interim staff to pharma, biotech and CROs across the UK

Our core specialist fields include:

  • Medical Information / Medical Affairs (including Med Info, Scientific Advisors, Medical Advisors, Final Signatory pharmacists and Medics, MSLs, medical directors)
  • Pharmacovigilance / Drug Safety (including QPPVs)
  • Regulatory Affairs

Other specialist fields we recruit for include:

  • QA & QC (including QPs)
  • Healthcare Compliance
  • Clinical Research (including CTMs/CSMs/CRAs/CTAs, CRPs)
  • Health Economics / Market Access
  • Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)

We have the ability to recruit for the areas above from junior level through to Director level.

Find Us
Website
Telephone
01227 844466
Location
Clover House
John Wilson Business Park
Whitstable
Kent
CT5 3QZ
GB
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