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Drug Safety Assistant Belgium,  


Posted on : 11 April 2017

Project Description

Business LineQA, HSE and Drug SafetyJob DescriptionWe are looking for a Drug Safety Assistant for one of our clients based in Walloon Brabant. SCOPE : Support safety alliance management activities (eg SDEA drafting, review, negotiation, termination, issue escalation) for low risk partners in accordance with the company's standards and in collaboration with relevant global and affiliate stakeholders. Support maintenance of audit CAPA tracker. Maintain SDEA internal periodic review status and ensure appropriate follow-up with the company's Local Safety Officers. Support maintenance of SDEA related data in the Centralized Safety Agreement Management Database. Profile University or medical background Pharmacovigilance understanding with at least 3 years of experience in Pharma industry Safety Data Exchange Agreement (SDEA) exposure to understand the requirements (2 to 3 years) Legal understanding; Excellent reading & writing skills in English Understanding and experience with licensing, distribution or promotion agreements; Excellent skills in Microsoft Office Tools. What we offerYou will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.Who we areKeyrus Biopharma is an international full-service CRO with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. From early- to late-stage clinical development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information. CategoryPharmacovigilanceLocationWalloon BrabantContact person DD Diakho

Locations

Walloon Brabant Belgium

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