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 3 months, this may be extended. The hours of work are 18.5 a week - home based working.
Company: 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.
Location: This Pharmacovigilance Specialist role will be based at our clients site in Hull, East Yorkshire.
- 18-24 per hour, PAYE.
Pharmacovigilance Specialist Role:
- 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.
- 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.
- Ensure the submission of Individual Case Safety Reports and expedited reports to Authorities within mandatory timeframes.
- At least 3 years Pharmacovigilance experience a must. 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.
- Building Strong Relationships (including across cultural boundaries).
Apply: For more information or to apply for this Pharmacovigilance Specialist position, please contact Julie on 01438 870011 or email firstname.lastname@example.org, quoting job ref 48685.It is essential that applicants hold entitlement to work in the UK.