Global Product Safety Scientist
vor 6 Monaten
**Company Description**:
- Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere._
The Global Safety Scientist has a key role within Global Pharmacovigilance & Patient Safety (GPV) and is responsible for 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 GPV 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 (GPSSL) for assigned product(s) as well as with other PV functions, to ensure that safety surveillance activities are delivered to ethical and safety quality standards to ensure the safety of patients and to be in compliance with GVP, GCP and worldwide 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 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
**Qualifications** 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 build
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