Risk Management Expert (Pharma)

About UsConsultys Group is a 100% specialist LifeScience consulting firm. With more than 550 experts working in France, Belgium, Germany and Switzerland on major engineering, R&D and compliance projects for the world’s leading pharmaceutical, medical device and biotech companies. Consultys links operational compliance, quality, processes, R&D, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.Role & ResponsibilitiesExecute and support all local pharmacovigilance and Risk Management (RM) related activities Communicate efficiently and effectively with Local Service Providers to support timely processing of orders and ensure compliance to RMPsCollaborate with supply chain and customer care to perform reconciliation of Prescription Authorization Forms (PAFs) submission against supplyContribute to the development, update and maintenance of SOPs/WPs and associated documentsComplete adverse event reconciliations for vendors involved in, but not limited to, patient support programs, medical information and investigator-initiated trials on a frequency determined by the agreementReview and input into safety sections of abbreviated prescribing information for newly authorized medicines and for updated Summary of Product Characteristics (SmPCs)RequirementsUniversity Degree in Sciences, Engineering or another relevant disciplines3 years of experience in the production of active ingredients and in the GMP environment (experience in biotechnological production is an advantage)At least 2 years of experience in the application of quality risk management methodsAnalytical and structured working style; strong attention to detailAbility to effectively work as part of a multidisciplinary, international teamFluency in English is required, German, French or Italian would be a plus