Medical Affairs Officer – Pharmakovigilanz

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 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
• You will work closely with hameln pharma business partners worldwide to maintain and develop strong working relationships that ensure effective and compliant exchange of safety data.

You will work closely with the QPPV, Medical Affairs colleagues and third-party providers to deliver services to all hameln companies and business partners worldwide.

• Receipt and triage of safety data from all sources, including spontaneous reports from patients and healthcare professionals, literature sources, MHRA, EMA and national regulatory authorities worldwide, with entry in the Oracle Argus Safety Database for subsequent processing.
• Processing of ICsS, 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 ICsS and articles considered to be relevant to the ongoing assessment of the benefit-risk profile of products in the hameln portfolio.
• 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 aggregate safety reports (e.g. PSURs, PBRERs) alongside colleagues from the Medical Affairs team, including review of received safety data in the context of cumulative data, labelling for innovator / competitor products and clinical/ professional society 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 labelling, including SmPC, PIL and packaging artwork.
• Product maintenance and development with a strong focus on 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.

• 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 be considered an advantage.
• You have a clear understanding of current and developing legislation, ethics and…