Drug Safety Associate (Operations)

Recruiter
DOCS Global
Location
Bedfordshire
Posted
18 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Roles & Responsibilities of the positionKey Responsibilities • Ensure that adverse events/product complaints are actively collected and all methods for collection are in place and available to all internal and external customers. • Ensure compliance with local and global regulatory requirements and GPS documentation. • Ensure that appropriate communications occur between patient safety locally and the assigned Global Patient Safety Regional Centre and with various other Client departments e.g. product complaints, medical, regulatory affairs, legal, sales. • Provide advice and guidance on Adverse Event Product Complaint reporting to other functions within the UK Affiliate. • Perform In-Box monitoring and workload balance, as needed. • Perform reconciliation and sample checks with Medical Information, Third Party Organisations (TPOs), Patient Support Programs, Market Research Programmes, and other sources for reporting, as appropriate. • Perform Quality Check of cases booked into LSS. • Have a general understanding of the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV). Adverse Event Case Management • Act as a point of contact for receipt and collection of initial and follow up Adverse Event (AE)/device reports via email, fax, post, and phone or in person. • Communicate AE/device information to GPS Regional Centre. • Conduct follow-up as directed or required.Job RequirementsMinimum Requirements: • Bachelor’s degree (or higher) in a health care-related or life science field or equivalent demonstrated experience is required. • Effective communication skills (verbal and written). • Proficient in Microsoft Office suite. • Knowledge of medical terminology. • Ability to manage multiple concurrent tasks. • Excellent organizational and time-management skills. • Detail-orientated. • Effectively analyze possible solutions to solve a range of problems. • Effectively respond to client requirements and requests. • English language skills – fluent written and verbal communications. • Work effectively in team environment. • Knowledge of medical terminology and coding systems.Remuneration & other details• Excellent Opportunity to work within a leading pharma company • 23 days holiday increasing to 27 days • Bupa • Pension • Permanent position • Office based in Windlesham, Surrey

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