Medical Affairs Officer – Pharmacovigilance in Gloucester

Overview

Your mission as a Medical Affairs Officer (Pharmacovigilance) is to be a key member of the office-based team, managing global safety data and business partnerships while 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.

Responsibilities

• 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 EudraVigilance (EVWEB) and the MHRA Portal.
• 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.
• 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.
• Aggregate safety reports: Co-authoring and reviewing PSURs, PBRERs, and related safety data.
• 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).
• Safety-related information: Product labeling, including SmPC, PIL, and packaging artwork.
• Product maintenance and development with regulatory compliance: Supporting new Marketing Authorisation applications.
• Horizon scanning: Systematic, proactive knowledge sharing, including recommendations for action.

Your profile

• 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.
• You have a clear understanding of current and developing legislation, ethics, and practice.
• You have outstanding communication and medical writing skills with exceptional attention to detail.
• You bring an understanding of the principles of information management including data sources, collection, assessment, and storage.
• You have the ability to build and maintain effective working relationships with cross-functional and multinational colleagues.
• You have the ability to meet deadlines while managing multiple responsibilities.
• You bring professionalism and integrity.
• You have the ability to learn quickly and adapt rapidly in a dynamic environment.

Why us?

This is an excellent opportunity to take responsibility and develop and broaden your skills in this important role within our well-established global Medical Affairs department. There will be continuing support for ongoing professional development and for the right candidate, there is flexibility in the role and responsibilities we can offer. We offer a competitive salary alongside wider company benefits.

About us

hameln pharma gmbh is a dynamic, successful, medium-sized company specialising in the marketing of generic parenteral drugs used in the hospital sector, primarily in anaesthesia and intensive care medicine. We offer our products in over 45 countries worldwide via international networks, affiliates, and business partnerships.