CK Group is recruiting for a Pharmacovigilance Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Hull for a 6 month initial contract and has an hourly rate of £20.79 PAYE.
The Company: Our client is a company that supports healthcare professionals in over 100 countries in an effort to improve the lives of their patients. The company takes a pioneering approach to the design of advanced medical products and services by securing wider access to their diverse technologies for more customers globally and by enabling better outcomes for patients and healthcare systems. They hold leading positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine to name a few.
Location: Hull is a port city in East Yorkshire, is named as the UK's City of Culture 2017. The city is at the eastern end of the M62 and can be easily accessed from the rest of the UK motorway network. It has good access from Lincolnshire and the south via the A15 and the Humber Bridge, and can be accessed by the A1079 from York and the North.
The job function will provide a professional Pharmacovigilance Service as part of a team supporting the design, development and ongoing commercialisation of clients pharmaceutical and biological products, within the Advanced Wound Management Division.
- To ensure compliance with Pharmacovigilance Legislation - Regulation (EC) No 1235/2010 & Directive 2010/84/EU.
- Assist in the management of the company pharmacovigilance system, ensuring the adequacy of pharmacovigilance activities and the maintenance of the Pharmacovigilance System Master File.
- To assist in ensuring that the conduct of all pharmacovigilance activities is in accordance with company procedures, applicable legislation and Good Vigilance Practice.
- Participate in the signal evaluation processes for the products and ensure the timely review all signals. Provide input to the medically trained person(s) and the product safety experts for the causality, seriousness and expectedness assessment of adverse events.
- To ensure the submission of Individual Case Safety Reports and expedited reports to Authorities within mandatory timeframes.
- Ensure the accurate completion of MedDRA coding of Adverse Events and Adverse Drug Reactions, as required for PSURs/PBRERs and expedited reports.
- Assist the medically trained person as necessary to follow-up with healthcare professionals and/or consumers for serious cases in EU to obtain additional information, including information relating to use of products in pregnancy.
- Maintain awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety and the safe use of the products.
- To assist in the preparation of Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports and Assurance of Compliance in accordance with the regulations.
- Assist in the preparation of Company responses to emerging safety concerns, including variations, urgent safety restrictions, and communication to patients and healthcare professionals.
- Assist in the review of all product labelling related information, (including final approval), whenever safety aspects are concerned.
- Maintain awareness of Pharmacovigilance Audit Schedules and supervise CAPA plans, both internally and for companies performing delegated tasks.
- Assist in ensuring that provision for safety data exchange is made in licensing agreements which may impact Company reporting in the EU.
- Degree or equivalent in a relevant discipline, e.g. Pharmacology, Medicinal Chemistry, Biology, Toxicology.
- Pharmacovigilance qualification, desirable.
- Good interpersonal skills are essential.
- Comprehensive understanding of the EC Pharmacovigilance regulations: 2001/83/EC, Regulation (EC) No 726/2004 and other associate European legislation and standards, including the Good Pharmacovigilance Practice Modules.
- Knowledge of issues relating to the safety and clinical use of pharmaceutical and biological products.
- Experience of working in a regulated environment.
For more information or to apply for this position, please contact Julie on 01438 723500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46663 in all correspondence.