
Posted 8 days ago
Global Product Safety Scientist
SobiGlobal Product Safety Scientist
Requirements
University degree in biosciences, healthcare, or pharmacy, PhD preferred, 3+ years pharmaceutical industry experience, Knowledge of pharmacovigilance regulations, English fluency
Skills
PharmacovigilanceDrug Development
About the role
Responsibilities
- Collaborate with the Global Product Safety Science Lead to develop and implement safety science strategies for assigned products.
- Contribute to multidisciplinary Benefit Risk Teams, including signal detection, analysis, validation, and risk management.
- Provide clinical safety input to study teams and potentially serve as a study-level Safety Lead.
- Support the creation and maintenance of core and EU Risk Management Plans (RMPs).
- Lead the preparation of periodic safety reports such as PSURs and DSURs.
- Monitor and evaluate incoming safety information to identify potential safety signals.
- Contribute to regulatory submissions and product safety documentation.
- Liaise with external service providers to ensure timely delivery of safety science documents.
- Support audits and inspections related to product safety.
Requirements
- University degree in biosciences, healthcare, or pharmacy (PhD preferred).
- Minimum 3 years of post-graduation experience in the 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, problem-solving, and team leadership capabilities.
- Experience in process development, implementation, and oversight.
Preferred Qualifications
- Proven experience delivering results within a matrix safety team.
Benefits
- Competitive compensation with a base salary range of $160,000-$187,000.
- Eligibility for short-term and long-term bonuses.
- Generous time off policy and emphasis on work/life balance.
- Opportunity to attend professional conferences.
- Collaborative and team-oriented work environment.
About the Company
Sobi is a specialized biopharmaceutical company dedicated to developing and delivering innovative therapies for people living with rare diseases. With over 1,900 employees in more than 30 countries, we are committed to making a positive impact on the lives of patients through science and strong partnerships.
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Sobi · Raleigh
