The Global Product Safety Scientist is directly responsible for providing scientific expertise to safety surveillance and risk management activities for one or more Sobi development and/ or marketed products.  You will be part of a collaborative team made up of safety leads and safety scientists. Key responsibilities include but are not limited to:

• For the assigned product(s) coordinate multidisciplinary product level Benefit Risk Team meetings for signal detection, analysis and validation, risk management and minimization strategies, risk communication, and safety labelling activities
• Contribute to clinical safety science interactions with partner companies for the product (if applicable) to ensure effective clinical safety science interactions including ensuring sharing of safety information per the SDEA and the collaborative functioning of the joint safety management team (JSMT)
• Create, extract and/or prepare all types of listings from data sources required from the Sobi Safety Database, or other applicable sources, for the purpose of signal detection, safety surveillance/analysis and regulatory submission activities.
• Lead the collection of material for periodic reports e.g. PSURs and DSURs and contribute to the risk evaluation and the benefit-risk assessment for the assigned product(s).
• Be main author and coordinator for the production and maintenance of core and EU RMPs and work with stakeholders to support the preparation and maintenance of local RMPs
• Provide high quality and timely contributions to responses to safety-related enquiries for Sobi products i.e. from regulatory authorities and other sources requiring input from GPV.
• Be the safety representative in clinical study teams, including providing safety input to design, conduct data analysis and interpretation. Work in close collaboration with PV Operations to ensure appropriate study case processing.
• Provide safety expertise to CTD submission, regulatory interactions and defence, and geo-expansion beyond initial License Applications (NDA/BLA) and MAAs
• In alignment with the GPSSL drive monitoring, aggregation, review, analyses, interpretation, and evaluation of incoming safety information and highlight potential safety signals
• Work collaboratively, effectively and flexibly with the GPSSL to complete safety deliverables and activities to ensure continuity of safety support
• Work across PV with the product assigned Partnership and Operations Manager to contribute to product specific case management guidance documents and trainings e.g. Product Safety Information
• Contribute to development and maintenance of safety related systems, processes, and procedural documents
• Support audits and inspections for pre-inspection requests as well as during audits and inspections

Education/Learning Experience/Work Experience

• University level qualification in biosciences, healthcare, or pharmacy. A PhD in a topic relevant to the position is preferred
• At least 3 years´ experience post graduation in the pharmaceutical industry, preferably in Patient Safety and/or Clinical/Drug Development, or at a regulatory agency
• Previous experience in pharmacovigilance, including advanced/solid knowledge of PV regulations and cross-functional working

Skills/Knowledge

• Analytical skills
• Ability to work proactively, independently, and collaboratively with colleagues
• Team-leadership capabilities.
• Relationship builder and collaborator within PV functions Experience, expertise, determination, and courage to solve problems or escalate issues as appropriate
• Effective communicator with peers, internally and with partner functions
• Preferred experience in process development, process implementation, training development and process oversight
• High quality written and spoken English

Personal attributes:

• Problem solver, developer of analysis and deliver plans. Proven delivery focus
• Effective team player

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.