Pharmacovigilance & Regulatory Affairs Manager - For Netherland Resident Only

7 dagen geleden

Utrecht, Nederland Alfasigma Voltijd

Location: Netherlands or Belgium, FlandersMaximaliseer uw kans op een succesvolle sollicitatie door ervoor te zorgen dat uw cv en vaardigheden goed aansluiten.Currently, we are looking for a Pharmacovigilance and regulatory affairs manager BeNeLuxJob SummaryResponsible for overseeing Regulatory affairs and Pharmacovigilance activities across the BeNeLux region, acting as the primary local contact for both internal stakeholders (local and global teams) and external partners (National Competent Authorities and consultants). Serves as the designated Local Safety Officer for the BeNeLux, maintaining high standards of patient safety and regulatory integrity.Your role:Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLuxAct as the Local Safety Officer (LSO) for the Netherlands, Belgium and LuxembourgAct as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMMResponsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to dateResponsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPsWork closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and supportCollaborate with commercial, medical and market access to realize cross-functional objectivesProfile description:Who are you?Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical companyKnowledge of local pharmaceutical legislation for Regulatory in the BeNeLux regionKnowledge of applicable laws and regulations to ensure full complianceKnowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)Proficiency in speaking, comprehending, reading and writing Dutch is required.Proficiency in speaking, comprehending, reading and writing English is required.Proficiency in speaking, comprehending, reading and writing French is a plus.Ability to think strategically & execute tacticallyWhat We OfferA dynamic and growing pharmaceutical environment.An ambitious, successful team to work with.Opportunities for professional growth and development.Competitive salary and benefits package.Why Join Alfasigma:At Alfasigma, we foster a culture where the courage to innovate is key to our success.We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. xbpjoel Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.

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