CK Group are recruiting for a Pharmacovigilance Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Hull on a contract basis for 6 months.
Up to £28.12 (PAYE) / £37.22 (Umbrella) per hour
Pharmacovigilance Specialist Role:
• 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 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
• Degree or equivalent in a relevant discipline, e.g. Nursing, Pharmacology, Biology, Toxicology
• Knowledge of issues relating to the safety and clinical use of pharmaceutical and biological products.
• 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 Pharmacovigilance regulations, specifically the regulatory reporting requirements in the US, Canada and other third countries, as applicable, to pharmaceuticals, biologics and OTC drugs.
• Knowledge of relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation (QSR), ISO 13485 and ISO 14971.
Our client takes a pioneering approach to the design of advanced medical products and services, holding lead positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine.
This Pharmacovigilance Specialist role will be based at our clients site in Hull, East Yorkshire.
For more information, or to apply for this Pharmacovigilance Specialist position please contact the Key Accounts Team on 01438 870011 or email firstname.lastname@example.org. Please quote reference 52730.
It is essential that applicants hold entitlement to work in the UK.