Medical Affairs Officer

Location
Gloucestershire
Salary
Competitive salary and benefits
Posted
05 May 2021
Closes
27 May 2021
Ref
0505MAOPV
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

DETAILS:

  • Full-time permanent position
  • Office based in Gloucester
  • Competitive package
  • Global pharma company

 

THE ROLE:

  • 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 source including spontaneous reports, literature sources, National Regulatory Authorities and the EMA
  • Literature review: Review of safety information published in the scientific literature.
  • The role will also involve wider aspects of Medical Affairs, including Medicines Information, Pharmaceutical Regulatory Affairs and new product development.

Full job description available on application

 

THE CANDIDATE:

  • 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

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.

Similar jobs

Similar jobs