Drug Safety Officer

Hobson Prior are looking for a Drug Safety Officer to join a leading healthcare organisation who are focused creating healthier communities all around the world. You will support the coordination of safety reporting requirements as required for Marketing Authorisation Holders and /or study sponsor, as applicable.

Job Responsibilities:

• Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company.
• Provision of safety information/acknowledgement to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
• Assist in the quality review of data captured in the Global Safety Database.
• Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
• Requesting additional information from multiple sources, both internal and external to the Company.
• Assist with assessment of incoming information from multiple sources, both internal and external to the Company.
• Continual monitoring and assessment of reportability of Individual Case Safety Reports due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and Notified Bodies (British Standards Institution (BSI)).
• Quality review of expedited assessments prior to submission.
• Provision of safety information to Competent Authorities/Notified Bodies within required regulatory timelines.

Key Skills:

• Ability to work effectively as a member of the Drug Safety and broader Medical Department teams.
• Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting modules.
• Ability to prioritise and work to strict timelines on a daily basis.
• Excellent verbal and written communication skills.
• Ability to negotiate and communicate with internal and external customers.

Requirements:

• Degree-level qualification (ideally in life science) or equivalent qualification.
• Awareness of and familiarity with industry principles of drug development and pharmacology.
• Proficiency in global and local SOPs.
• Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland.
• Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.