Global Safety Scientist

At Sobi, we are transforming life for people with rare diseases. As an international biopharmaceutical company, we provide access to innovative treatments in the areas of haematology, immunology, oncology and specialty care. Sobi is a biopharmaceutical company with in-house capabilities that stretch from late-stage R&D, biologics manufacturing and supply, to patient access and distribution.
The Global Safety Scientist has a key role within Global Pharmacovigilance & Patient Safety (GPV) in providing scientific expertise to safety surveillance and risk management activities including signal detection and evaluation for assigned product(s), where Sobi is the marketing authorisation holder or has product(s) in clinical development. The role actively contributes to setting the strategic direction within pharmacovigilance and to the development of safety standards and processes.
As part of our PV team you will be working collaboratively with the Global Product Safety Science Lead for assigned product(s) as well as with other PV functions to ensure that safety surveillance activities are conducted to the highest ethical and safety quality standards in compliance with GVP, GCP and regulatory requirements. You will also be working cross functionally within the company and with 3rd parties.
We are looking for a motivated and collaborative professional who will contribute to shaping our team, develop our systems and processes and drive effective collaborations across Sobi and with our partners.

The Global Pharmacovigilance & Patient 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 physicians and safety scientists. Key responsibilities include but are not limited to:

• Monitor, aggregate, review, analyse, interpret, and evaluate incoming safety information and highlight potential safety signals
• For the assigned product(s) coordinate Benefit Risk Team meetings including compilation and maintenance of the signal activities plan and provision of relevant safety input and contribution to the development of safety signal materials to be presented.
• 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 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. Lead the preparation of responses to assessment reports.
• Be the safety representative in clinical study teams, where you will be engaged in the study design, study set up, the running and conduct of the study and the interpretation of data, communication of the results and preparation for submissions e.g. new indications/drug approval
• Work collaboratively across Sobi functions to bring safety information together for assessment and interpretation, and aligned action planning
• Work across PV to coordinate product level PV across Operations, Systems and Science, including responsibility for the compilation of product specific case management guidance documents
• Development and maintenance of safety related systems, processes, and procedural documents including Global Process Owner roles
• Support audits and inspections for pre-inspection requests as well as during audits and inspections

Requirements

• 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.

Personal attributes:
• Ability to work effectively to deliver ambitious goals
• Work collaboratively in various cross-functional settings and as part of matrix teams
• Ability to work proactively, independently, and collaboratively with colleagues
• Relationship builder both internally and externally, a strong collaborator within PV function and the wider organisation
• Has the experience, expertise, determination, and courage to problem solve or escalate issues as appropriate
• Analytical skills
• Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive, and decisive
• Preferred experience in process development, process implementation, training development and process oversight

In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.