Medical Affairs Officer – Pharmacovigilance

Overview

Your mission As a Medical Affairs Officer (Pharmacovigilance), you will be a key member of the office-based team, where your primary responsibility will be the management of global safety data and business partnerships, alongside providing broader Medical Affairs support.

You will work as part of a global team to support safety data management, regulatory compliance and Medical Affairs activities across hameln pharma and partners worldwide.

• Take a leading role in the management of safety data from initial receipt and interaction with patients, healthcare professionals and partners, through assessment and reporting to regulatory authorities and subsequent audits and inspections.
• Work closely with hameln pharma business partners worldwide to maintain and develop strong working relationships that ensure effective and compliant exchange of safety data.
• Collaborate with the QPPV, Medical Affairs colleagues and third-party providers to deliver services to all hameln companies and business partners worldwide.
• In the field of Pharmacovigilance, be responsible for safety data management, including:
• Receipt and triage of safety data from all sources, including spontaneous reports, literature sources, MHRA, EMA and national regulatory authorities worldwide, with entry in the Oracle Argus Safety Database for subsequent processing.
• Processing of ICSRs, including download of cases from Eudra Vigilance (EVWEB) and the MHRA Portal, including: serious and non-serious national competent authority reports from the UK and EEA member states; serious national competent authority cases originating from third countries;
  Global Medical Literature Monitoring (MLM) service ICSR reports.
• Reporting to the relevant competent authorities within appropriate timelines.
• Literature review:
  Systematic review of safety information published in the worldwide scientific and local literature in partnership with third-party service providers, to identify ICSRs and articles relevant to the ongoing assessment of the benefit–risk profile of products.
• Quality Management System:
  Co-authoring, developing and reviewing related SOPs and Work Instructions.
• Business Partner Management:
  Authoring and management of pharmacovigilance agreements, periodic reconciliation, risk assessment and audit-related activities.
• Signal Management:
  From signal detection through to assessment and recommendation for action, including preparation and submission of safety-related variations.
• Aggregate safety reports:
  Co-authoring and reviewing PSURs, PBRERs and related safety data in context of cumulative data, labeling considerations and clinical/practice guidelines.
• Benefit–risk assessment and regulatory responses:
  Support benefit–risk evaluations, internal safety summaries and responses to safety-related questions from regulatory authorities and business partners.
• Risk Management and Risk Minimisation:
  Supporting the production, review and maintenance of Risk Management Plans (RMPs) and the implementation of additional Risk Minimisation Measures (aRMMs), including evaluation of their effectiveness.
• Safety-related information:
  Product labeling, including SmPC, PIL and packaging artwork.
• Product maintenance and development with regulatory compliance:
  Supporting new Marketing Authorisation applications (e.g. bridging reports), lifecycle maintenance and renewal activities.
• Horizon scanning:
  Systematic, proactive knowledge sharing, including recommendations for action.

• Opportunity to contribute to safety-related information and product lifecycle activities to support regulatory compliance and business needs.
• Safety-related information and labeling considerations as part of regulatory processes.
• Horizon scanning and proactive knowledge sharing with recommendations for action.

• You have successfully completed a degree in Biological or Biomedical Sciences. An additional postgraduate degree would be an advantage.
• You have relevant experience in pharmacovigilance and medicines/patient safety, ideally including significant experience in case processing and data entry. Prior experience using the Oracle Argus Safety Database would…