Job descriptionRole Title Pharmacovigilance Specialist Location Hull, UK with mostly remote working and occasional office visits Rewards Competitive salary, and comprehensive benefits on offer, including a generous pension. Summary At Smith & Nephew, we are constantly collaborating and innovating to ensure our products are relevant to the modern market. If you would like to become part of an ever evolving organisation, that has high standards at the core, then this vacancy will be of interest! The Pharmacovigilance Specialist uses their knowledge and experience to ensure we are in line with legislation in specific areas of the globe that we operate in. This particular role focuses mainly on the UK and European markets and offers the chance to expand knowledge across other areas too, we are offering a chance to work closely with a team of seniors who can offer mentorship and development within this unique area. There is an opportunity to showcase already learned skills, but also grow in breadth as this role has vertical coverage across the full scope of Pharmacovigilance. Is this the job for me? Evaluating information, adapting ways of working, and keeping close to the detail is what it's all about. If this sounds like you, then yes!
Due to promotion and secondment we have one permanent and one fixed term contract available. Essential Job Functions
- Maintain compliance with Pharmacovigilance Legislation
- Assist in the management of the company pharmacovigilance system, ensuring the adequacy of pharmacovigilance activities and the maintenance of the Pharmacovigilance System Master File
- Ensure the accurate completion of MedDRA coding of Adverse Events and Adverse Drug Reactions, as required for PSURs/PBRERs
- Is responsible for making decisions guided by policies, procedures and business plan; receives mentorship from Director PMS and senior PV specialist
- Pharmacovigilance experience
- Knowledge of issues relating to the safety and clinical use of pharmaceutical and biological products
- Evidence an understanding of the EU Pharmacovigilance Legislation - Directive 2010/84/EU & Regulation (EC) No 1235/2010, and other associated European directives and standards, including the Good Pharmacovigilance Practice Modules.
- Comprehensive understanding of UK Pharmacovigilance regulations, in particular the Human Medicines Regulations 2012 (HMR) (statutory instrument (SI) 2012 No. 1916, as amended).
- Knowledge of Pharmacovigilance regulations, specifically the regulatory reporting requirements in the US, Canada and other third countries, as applicable, to pharmaceuticals, biologics and OTC drugs.
- Experience of working in a regulated environment
- Degree in a related scientific or life sciences field
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