Medical Affairs Officer - Pharmacovigilance

Apex International Recruitment Ltd
South-West UK
Competitive salary and benefits and possible relocsation assistance
Closing date
3 Jul 2019

View more

Clinical Research, Drug Safety, Pharmacovigilance, Medical Affairs, Scientific Advisor
Full Time
Contract Type
You need to sign in or create an account to save a job.


  • Full-time permanent position
  • Office based near Bristol
  • Competitive package and possible relocation assistance
  • Pharma company



  • 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 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. 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.

Full job description available on application



  • A degree in the Life Sciences. A degree in Pharmacy or an additional postgraduate degree would be an advantage.
  • A minimum of 3 to 5 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
  • Only candidates with existing right to work in the UK/EU will be considered


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

To view our other vacancies, please visit our website on

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.

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.

Contact Us
  • The Blue Room
  • Kent Enterprise House
  • Herne Bay
  • CT6 7GQ
  • GB
  • 01227 844466
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert