Global Product Safety Scientist
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
- Contribute to the operation of the product level multidisciplinary Benefit Risk Team (BRT) including signal detection analysis validation risk management and safety labelling.
- Provide clinical safety input to study teams potentially serving as study level Safety Lead.
- Support the creation and maintenance of core and EU Risk Management Plans (RMPs).
- Lead the preparation of periodic safety reports (e.g. PSURs and DSURs) and contribute to benefit-risk assessments.
- Monitor review and evaluate incoming safety information to identify potential safety signals.
- Contribute to regulatory submissions interactions and product safety information in various documents.
- Liaise with external service providers to ensure strategic alignment and timely delivery of Safety Science owned documents.
- Support product-specific case management guidance and contribute to responses for medical safety enquiries.
- Participate in literature reviews and contribute to worldwide literature review strategies.
- Support audits and inspections related to product safety.
Qualifications :
Required:
- University level qualification in biosciences healthcare or pharmacy; PhD preferred
- Minimum 3 years post-graduation experience in pharmaceutical industry preferably in Patient Safety or Clinical/Drug Development
- Advanced knowledge of pharmacovigilance regulations and cross-functional working
- Excellent written and spoken English
- Strong analytical and problem-solving skills
- Effective communication and team leadership capabilities
- Experience in process development implementation and oversight
Desired:
- Proven delivery within a matrix safety team
Personal Attributes:
- Problem solver with a proven delivery focus
- Effective team player
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, the w ... View more
