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- Tasks: Join a dynamic team to ensure patient safety and compliance in pharmaceutical products.
- Company: Sobi, a global leader in specialty pharmaceuticals for rare diseases.
- Benefits: Inclusive workplace, flexible hours, and opportunities for professional growth.
- Why this job: Make a real difference in the lives of patients with rare diseases.
- Qualifications: University degree in biosciences or healthcare; PhD preferred.
- Other info: Collaborative environment with a focus on innovation and safety.
The predicted salary is between 36000 - 60000 £ per year.
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. 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 work we do every day redefines the standards of care and transforms the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
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 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
Global Product Safety Scientist in Cambridge employer: Sobi - Swedish Orphan Biovitrum AB (publ)
Contact Detail:
Sobi - Swedish Orphan Biovitrum AB (publ) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Product Safety Scientist in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Sobi. A friendly chat can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Research Sobi's products and their impact on rare diseases. Show us you’re passionate about making a difference.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the Global Product Safety Scientist role. We want to hear how you can contribute to our mission.
✨Tip Number 4
Don’t hesitate to apply through our website! Even if you don’t tick every box, we value diverse backgrounds and experiences. Your unique perspective could be just what we need!
We think you need these skills to ace Global Product Safety Scientist in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Global Product Safety Scientist role. Highlight any relevant experience in pharmacovigilance or clinical development, as this will show us you’re a great fit for the position.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about working at Sobi and how your background aligns with our mission to support rare disease patients. Be genuine and let your personality come through!
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention specific examples where you've successfully tackled challenges in your previous roles. We love to see candidates who can think critically and deliver results, especially in a fast-paced environment like ours.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re proactive and keen to join our team!
How to prepare for a job interview at Sobi - Swedish Orphan Biovitrum AB (publ)
✨Know Your Stuff
Make sure you brush up on your knowledge of pharmacovigilance regulations and safety science strategies. Familiarise yourself with Sobi's products and their impact on rare disease patients. This will show that you're not just interested in the role, but also in the company's mission.
✨Showcase Your Experience
Prepare to discuss your previous experience in the pharmaceutical industry, especially in Patient Safety or Clinical/Drug Development. Be ready to share specific examples of how you've contributed to safety reports or risk management plans, as this will demonstrate your hands-on expertise.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the role and the company. Ask about the current challenges the Global Pharmacovigilance team is facing or how they measure success in safety science. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
✨Emphasise Teamwork
Since the role involves collaboration with various teams, highlight your experience working in multidisciplinary settings. Share examples of how you've effectively communicated and led teams in past projects, showcasing your ability to be a team player and a leader when needed.
