Global Product Safety Scientist at Sobi

Raleigh, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

165000.0

Posted On

13 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Science Strategy, Pharmacovigilance, Signal Detection, Risk Management, Safety Labelling, Benefit Risk Assessment, Periodic Safety Reports, Regulatory Submissions, Case Management Guidance, Literature Reviews, Audits, Inspections, Analytical Skills, Problem-Solving Skills, Communication, Team Leadership

Industry

Pharmaceutical Manufacturing

Description

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 $120,000-$165,000. 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 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The Global Product Safety Scientist collaborates with the Global Product Safety Science Lead to develop and implement the Safety Science strategy for assigned products. Key duties include contributing to multidisciplinary Benefit Risk Teams, providing clinical safety input to study teams, and leading the preparation of periodic safety reports.