SABR Associate

Collabera Europe ltd ,
Maidenhead, Berkshire
More Details
Salary: £25 per hour

Overview

Hello everyone, Collabera is looking forward to recruit a SABR Associate to work with our client on an initial 12-month contract . Role Outline: You will be responsible for ensuring departmental compliance with regulatory requirements and department/company operating procedures. Responsibilities Include: Manages the delayed case investigation process by assisting SABR Management with delayed case investigations and reviewing the investigations to ensure root cause assignment can be made. Supports SABR Management team and corporate partnerships by developing and generating metrics and strategies to maintain regulatory compliance. Supports internal and external compliance audits as a Pharmacovigilance (PV) Quality Subject Matter Expert (SME) Participate in PV and Good Clinical Practice (GCP) audit and regulatory inspection preparation and execution. Tracks Individual Case Safety Report (ICSR) inquiry responses to regulators. Participate in departmental Continuous Quality Improvement (CQI) initiatives. Manages SABR PV documentation archiving according to corporate records management procedures. Experience and Qualifications Required: 1 - 3 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences. Strong organational skills and attention to detail Experience in conducting Pharmacovigilance audits (Qualification as an auditor preferred) Pharmacovigilance/clinical/industry/Regulatory Authority or otherwise relevant experience Knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device & Regulatory Affairs Strong technical skills with Microsoft Programs (Excel, Access and Word), Visio, and Adobe Acrobat Pro. Ability to exercise good judgment in determining objectives and approach to work assignment to maximize compliance Excellent written and verbal communication skills

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