Drug Safety Specialist

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development - Drug Safety, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Perform pharmacovigilance tasks, in alignment with the LRP-PV, for any products to maintain a benefit safety profile (including local signalling activities, risk assessment, implementation of additional risk minimisation measures)
• Support local processes for collection and follow-up of safety information from different sources (spontaneous and solicited, e.g., (non-)interventional clinical trials and other data collection programmes, local literature), manage and report safety cases internally through existing systems according to pharmacovigilance regulations for global, local and EDR (external drug safety responsibility) products, as required
• Monitor local Drug Safety contact channels (e.g. email) for safety information
• Assist in management of pharmacovigilance requests (e.g. questions, local data required for periodic safety report generation), audits and inspections
• Periodic monitoring for changes in local pharmacovigilance regulations
• Assist in standard procedural document management
• Assist LRP-PV in pharmacovigilance training of all employees or third parties
• Assist in drug safety agreement and service provider management
• Assist the LRP-PV in business continuity and back up processes
• Filing, tracking and archiving of the local pharmacovigilance related documentation (e.g. source documentation of safety cases, training, safety data, system checks, output of signal activities)
• Assist Global Drug Safety in Drug Safety international tasks/projects across territories to support pharmacovigilance activities (e.g. new products integrated into the local pharmacovigilance system)

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• Relevant experience/understanding of the pharmaceutical industry, including pharmacovigilance and relevant operational pharmacovigilance experience
• Scientific degree
• Local language skills for countries within the UKINOR Cluster beneficial (UK, Ireland, Denmark, Norway, Finland, Sweden, Iceland), business English language
• Microsoft based and general IT competence
• Able to support less experienced colleagues and ability to work across matrix environments
• Taking ownership and being proactive to seek improvements whilst working in a matrix environment
• Passion for pharmacovigilance
   

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