Medical Affairs Officer

Hobson Prior are looking for a Medical Affairs Officer to join a pioneering pharmaceutical organisation who are focused on the development, licensing and marketing of generic injectable medicines. If you'd like more information on this role then please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Accountable for the maintenance of the Pharmacovigilance System and PSMF.
• Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information.
• Review of safety information published in the scientific literature.
• Processing and reporting spontaneously received post-marketing safety data including its receipt, tracking, coding, assessment and submission to regulatory authorities.
• Maintenance of cumulative safety data received from all sources including spontaneous reports, literature sources, National Regulatory Authorities and the EMA.
• Signal management from signal detection through to assessment and recommendation for action.
• Production, review and maintenance of Risk Management Plans and implementation of risk minimisation activities including effective use of product labelling and (when required) additional materials.
• Production, review and maintenance of effective Safety Data Exchange Agreements between the company and its business partners.
• Maintaining the PV Quality Management System and undertaking associated quality-related activities including Audit, Compliance Monitoring and Quality Improvement. SOP authoring and management.
• Authoring of safety-related information including updates to product labelling (SmPC, PIL, packaging) and coordination of associated regulatory activities.

Key Skills:

• The ability to build and maintain effective working relationships with cross-functional and multinational colleagues.
• The ability to meet deadlines while managing multiple responsibilities.
• Professionalism and integrity.
• Outstanding communication and medical writing skills with exceptional attention to detail.
• The ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers including business partners and healthcare professionals.

Requirements:

• A degree in the Life Sciences (a degree in Pharmacy or an additional postgraduate degree would be an advantage).
• At least 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.