Global Product Safety Scientist

Company Description

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, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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.
• 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

Additional Information

Compensation and Total Rewards at Sobi

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $160,000-$187,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,900 employees in more than 30 countrie