Sourcing Statement You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV. Job Description RMP coordinator Sandoz Romania is a position in the Commercial department, responsible for ensuring proper local implementation of Risk Management Requirements prior and after their launch, according to internal company standards, policies, procedures and health authority requirements, in order to safeguard the patient safety and company reputation.Your key responsibilities:Your responsibilities include, but are not limited to: • coordinating the local multi-disciplinary team in performing the safety commitments in their responsibility:• permanent oversight of key activities in each department involved, acting and mitigating any potential risk for patients, according to specific RMP requirements, e.g.:o monitoring specific training compliance at all levels (internal staff training on RMP and Educational Materials, Controlled distribution program, train-the trainer program, external training compliance, including proper distribution to educational materials to all external stakeholders involved)o monitoring registration and enrollment of external stakeholders for conducting RMPs’ requirements (e.g., enrollment of wholesalers, pharmacy chains, independent pharmacies, prescribers)o monitoring the process of developing, updating and distribution of Educational materials according to the Distribution Plan, performed via internal staff teams and/or external suppliers, using all established and approved communication channelso monitoring the effectiveness of implemented risk mitigation measures – e.g. Prescription Authorization Forms management, all specific local steps of Reconciliation process in CDS Lenalidomide Sandoz;o is able to timely identify, evaluate, address and/or escalate any safety or pregnancy risk resulting from insufficient implementation of RMP requirementso coordinates development and proper addressing of corrective actions and preventive actions in case of non-conformities and deviations to the local procedures in all functions involved, aiming to continuously improving the processes, protecting the patients’ safety and company reputationo ensure keeping accuracy and completeness of internal records and meeting all deadlines for periodic Country reports required by all RMPso monitoring the proper archiving of all documentation required by RMP, as proofs of local implementation of required activities in all department involved, ensuring immediate retrieving of documents in case of Audits and Inspectionso ensure business continuity in all RMP steps in all lines of responsibilities, by alignment with representatives of all functions involvedo reporting for various commercial data• The role is representing the key point of contact with Global Task Force RMP teams, Regional/Global Patient Safety, Regional/Global Risk Management, Region/Global Quality, as well as with Country Head/President, for periodic update of RMPs local implementation and/or communication or escalation of non-conformities or local challenges/legislative restrictions, if applicable. Minimum requirements What you’ll bring to the role:• Proven experience with RMP implementation and maintenance• University degree• Fluent English (both written and spoken)Why Sandoz? million patients were touched by Sandoz generic and biosimilar medicines in and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Sandoz!Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
RMP coordinator Sandoz Romania in Bucuresti
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