Global Safety Scientist at Sobi

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

22 Apr, 26

Salary

0.0

Posted On

22 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Signal Detection, Risk Management, Safety Labelling, Clinical Study Support, Data Analysis, Regulatory Submissions, Analytical Skills, Attention to Detail, Communication, Team Collaboration, Problem Solving, Patient Safety, Ethical Practices, GVP, GCP

Industry

Pharmaceutical Manufacturing

Description

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. Job Description The Global Product Safety Scientist (GPSS) is responsible for providing safety scientific expertise and works with the Global Product Safety Science Lead (GPSSL) to develop and implement the Safety Science strategy for assigned Sobi products. The GPSS works collaboratively together with the GPSSL and other members of the Sobi Global Pharmacovigilance team, together with other functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements. Key Responsibilities: Collaborate with the Global Product Safety Science Lead (GPSSL) to develop and implement the Safety Science strategy for assigned Sobi products. Lead the Benefit Risk Team (BRT) activities, including signal detection, analysis, validation, risk management, and safety labelling. Contribute to clinical study teams, providing safety input for design, conduct, data analysis, and interpretation. May act as study-level Safety Lead. Support safety science interactions with partner companies, ensuring information sharing and collaborative functioning of the Joint Safety Management Team (JSMT). Drive monitoring, review, and evaluation of safety information, highlighting potential safety signals. Lead the preparation of periodic reports (e.g., PSURs and DSURs) and risk management plans (RMPs). Provide safety expertise for regulatory submissions, interactions, and product expansion activities. Contribute to the development and maintenance of safety-related systems, processes, and procedural documents. Support audits and inspections related to pharmacovigilance activities. Collaborate with cross-functional teams to ensure compliance with GVP, GCP, and worldwide regulatory requirements. Qualifications Education and Experience: University level qualification in biosciences, healthcare, or pharmacy; PhD preferred Minimum 3 years' post-graduation experience in pharmaceutical industry or regulatory agency Solid knowledge of pharmacovigilance regulations and cross-functional working Skills and Knowledge: Proficiency in signal detection, risk management, and safety labelling Experience in preparing periodic safety reports and risk management plans High quality written and spoken English Strong analytical skills and attention to detail Thorough understanding of GVP, GCP, and worldwide regulatory requirements Personal Attributes: Effective communicator and team player Sound judgement skills; able to assess and handle risks Problem solver with proven delivery focus Adaptable to fast-paced environments Commitment to patient safety and ethical practices Sobi Location: Sweden

Responsibilities

The Global Product Safety Scientist is responsible for providing safety scientific expertise and collaborating with the Global Product Safety Science Lead to implement the Safety Science strategy for Sobi products. Key responsibilities include leading safety activities, contributing to clinical study teams, and ensuring compliance with regulatory requirements.