Senior Pharmacovigilance Officer |£45000 - £50000 per annum
Pharma & Science
South East

Senior Pharmacovigilance Officer

Additional Information

Location: High Wycombe

Salary: £50,000

Hours: Monday to Friday 37.5hpw

Job Type: Permanent

Purpose of the role

The Senior Pharmacovigilance Officer is responsible for supervising and quality checking the collection, processing, reporting and following up of pharmacovigilance reports. In addition, they participate in regular signal detection/safety review activities, prepare periodic reports and Risk Management Plans (RMPs), assist with regulatory intelligence and provide training in pharmacovigilance activities.

Main Responsibilities and Duties

  • Participate in regular signal detection/safety review activities
  • Preparation of periodic safety reports
  • Preparation of RMPs
  • QC the assessments of the outputs from world-wide literature searches and evaluate them for ICSRs or relevant safety information on the company products
  • QC the triage, processing and follow up all ICSRs for all company products in accordance with applicable regulations, SOPs and safety data exchange agreements
  • Assist with the preparation of SDEAs
  • Provide training in pharmacovigilance activities to other team members
  • Assist with the preparation, review and update of the pharmacovigilance SOPs
  • Develop in-depth knowledge about the legislation, regulations and guidance related to pharmacovigilance
  • Develop scientific and technical product knowledge
  • Any other duties or projects as requested by the line manager commensurate with the grade and level of responsibility for this role, for which the incumbent has the necessary experience and/or training

Experience and Qualifications




Educational Level

University Degree in Medical/Biological/Life science or related scientific field


Minimum 4 years in pharmacovigilance, including participating in signal detection activities

Professional Qualifications

MSC / Post graduate Diploma in PV qualification


Good understanding of EMA GVP Modules

Knowledge of PV regulations outside of the EEA

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