Project Associate- Product Surveillance- Contract Role
Pharmaceutical Company based in Buckinghamshire
Our client is a leading pharmaceutical company, located in Buckinghamshire. Working across multiple therapy areas, they research and develop both ethical and consumer health products and devices in a range of therapy areas including dermatology, ophthalmology, neurology and other speciality markets.
Located within easy reach of the M40, and mainline BR, our client boasts modern spacious offices with ample free car parking. Generally speaking, roles with this client are fully office based and there is limited scope for home working. Office facilities include onsite restaurant, and a relaxed 'coffee shop' area.
CSL are privileged to have a longstanding relationship with this client and have made many placements both for permanent and contract openings so can really vouch for them when we say that candidate feedback is extremely positive and this is a great place to work.
Under the direction of the Associate Director Product Surveillance EAME, you will be responsible for managing, analysing and creating reports in response to requests for information, liaising with US Product Surveillance team as required. Identify and manage process improvement projects in response to audit findings, system analysis, internal requests and personal experiences from the individual and the team.
In the absence of the Product Surveillance Analyst/supervisor or AD you will be attending:- Clinical Operations meetings to provide input and direction with regards to Medical Devices Directorate guidelines and providing support and advice to the Product Surveillance Analyst, Clinical R&D. Presenting^at the Operations Management Review meetings, providing feedback and advice to other functions within our client as required regarding Product Surveillance activities and policies. Also be responsible for carrying out Supervisor Risk Assessments, approving Vigilance Reports in TrackWise and providing support, supervision and advice to the Product Surveillance team as required.
Projects could include reviewing part or all of a process within Product Surveillance and identifying potential cost^and time savings potentials . Presenting this in a management report and then managing/leading the activities to achieve the savings. This may involve other offices in EAME and SB so cross-matrix management of the project resources would also be part^of the scope.
Other responsibilities would be to improve the current explanted device return process; identifying international laws and regulations regarding shipment of contaminated devices, alternative compliant packaging, resolving the management of logistics across EAME and to USA, introducing the new packaging/process and updating applicable controlled documents.
Working with Clinical teams, both in UK, US to ensure that the process for reporting AEs, SAEs, etc enables time sensitive activities to be complete within regulatory timelines. Helping to Identify improvements to the existing system.
Essential Skills & Qualification
Science or other analytical degree level qualification or equivalent preferred, ideally further educational qualification demonstrating research skills - or equivalent work experience in a related field.
In depth experience of working with and interrogating databases
Experience of managing projects to successful conclusion
Experience of Microsoft software applications (Word, Excel, PowerPoint)
Experience of working with and following clearly defined Standard Operating Procedures
Experience of following Good Documentation practices applicable to Pharmaceutical/Medical Device requirements^is essential
Experience of working to the Medical Device Directive requirements would be an advantage.
Experience of cross cultural and functional working
Medical Device experience is essential, whether it be from QA, Regulatory or Product Information.
Able to successfully manage a large number of projects with differing timelines simultaneously
Fully competent in Microsoft Word, Excel and TrackWise (or other databases)
Software Competence: MS Office, MS Project, DOCUMENTUM
Working Language(s): English
Requirement for Business Travel: No
Flexible Working Hours:To be confirmed
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 6 Months
Location: UK; Location Independent, Office Based access near M4/M40
Plan Start Date: ASAP
Contract Benefits: Day Rate inclusive of benefits
Documentum, AEs, SAE's, Trackwise, Clinical R&D, Regulatory, Devices
Assigned Consultant:Sue Spice at CSL Recruitment on 01932 228928 or email email@example.com
Please feel free to call for a detailed Job Description or additional information
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