Pharmacovigilance Specialist

Polar Speed Distribution Ltd ,
Leighton Buzzard, Bedfordshire
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Overview

POLAR SPEED DISTRIBUTION LIMITED Polar Speed, a UPS company, is a logistics company and innovative provider of temperature sensitive transportation and pharmaceutical supply chain solutions in the UK. JOB TITLE: Pharmacovigilance (PV) Specialist HOURS: 37.5 Hours, Monday – Friday, Covering Pharmacy opening 08:00 – 18:00 Hrs BASED: To cover Pharmacies in Leighton Buzzard and Tamworth, could essentially be based in either location but must be prepared to travel between the two sites. SALARY: Dependent upon experience. Polar Speed has a reputation for quality, compliance, operational and customer facing technology and monitoring solutions in the growing temperature-sensitive pharmaceutical logistics market in the UK. The company specialises in active temperature-controlled deliveries to hospitals, pharmacies, wholesalers and medical care surgeries as well as to end patients which it serves through its homecare business. Its customers include some of the best known pharmaceutical brands in the world. As the Pharmacovigilance Specialist (PV) you will play a vital role in ensuring the Pharmacy and our client requirements meet and exceed the regulatory standards. You will be responsible for the implementation and maintenance of an effective Pharmacovigilance system, identifying and delivering process improvements to PV reporting and reconciliation to achieve the client KPI requirements. Coordinate and implement all the Polar Speed PV training requirements ensuring a robust daily capture and reporting of all adverse events (AEs). This role requires a candidate who can work on multiple tasks in a busy and pressurised environment whilst maintaining the highest levels of quality service, problem solving and providing innovative solutions. To deal effectively with the complex issues that occur within this role you will need to have excellent organisational skills, take a proactive approach and work well under pressure. The ability to build excellent internal and external stakeholder relationships and nurture and develop a team are essential. Working 37.5 hours per week between the hours of 0800 and 1800 on a Monday to Friday basis, you must be flexible and prepared to work additional hours as and when required to meet our service requirements which may be of an urgent medical nature. We offer a wide range of benefits including 28 days’ holiday (including bank holidays) building to 33 days (including bank holidays) in the sixth full holiday year and a company pension. For successful applicants, Polar Speed will process enhanced disclosure criminal record checks. Key Skills/Experience/Requirements: 1. Perform a daily review of all PV touch points to ensure all AE’s are reported within 24 hours. 2. Maintain an effective PV process to ensure Pharmacy and the broader Polar Speed organisation to achieve and where possible exceed client expectations. 3. Review and update the PV Standard Operating Procedures (SOP’s) in line with the process changes. 4. Identify gaps in the PV procedures and work with the appropriate team members to fill these gaps. 5. Maintain and implement when required contingency plans to ensure all AE’s are reported correctly in the event of a service challenge. 6. Ensure compliance to all SOP’s impacting on PV by performing self-inspections/audits and use the findings to produce or develop CAPA plans ensuring continuous improvements. 7. Deliver and maintain oversight of all staff and their PV training requirements and support senior team colleagues to achieve the required KPI. 8. Maintain accurate records and ensure retention is in accordance with regulatory and company requirements. 9. Support the Pharmacy risk register and coordinate the delivery of risk management plans through senior team colleagues. 10. Complete incident/ Non Conformance reporting timely and support Root Cause Analysis and the subsequent delivery of the CAPA plan and effectiveness checks of all agreed actions. 11. Complete all relevant reports accurately and on time. 12. Support all the pharmacy PV audits, both internal and external and support the delivery of all subsequent actions accurately and in a timely fashion. 13. Maintain the pharmacy KPI dashboard for PV. 14. Act as the main PV contact for all enquiries the company may receive. 15. Complete all relevant reports and administration duties accurately and on time. Key Skills: 1. High standard of organisational, communication and interpersonal skills. 2. An excellent understanding of all areas of patient safety. 3. Excellent attention to detail whilst working on multiple projects with different deadlines. 4. KPI management experience. 5. Experience of Microsoft packages. 6. Team management and development experience. Specialist Knowledge: 1. Pharmacy qualifications and excellent knowledge of PV regulations 2. Experience of managing and supporting Internal/External audits and CAPA management. 3. Working Knowledge of Pharmacy regulations, RPS homecare standards; NHS policies and procedures. 4. MS Office to proficient level (Word, Excel, Outlook) 5. DH homecare guidance. 6. NVQ3 or degree or equivalent This job was originally posted as www.totaljobs.com/job/89946144

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