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- Tasks: Lead safety science activities for innovative pharmaceutical products and ensure patient safety.
- Company: Join Sobi, a global leader in specialty pharmaceuticals for rare diseases.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in patients' lives while working with cutting-edge science.
- Qualifications: Advanced biomedical degree and extensive experience in clinical safety and pharmacovigilance.
- Other info: Collaborative environment with a focus on ethical standards and regulatory compliance.
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.
The Global Product Safety Science Lead (GPSSL) is responsible to strategically lead the Safety Science activities for assigned Sobi products. The GPSSL leads the safety science engagement throughout the product lifecycle including the development and maintenance of the clinical safety profile of the product, the ongoing safety surveillance and management, and the effective and timely communication of clinical safety to internal and external stakeholders. The GPSSL works collaboratively with the Global Product Safety Scientist (GPSS) 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
- Lead the product level multidisciplinary Benefit Risk Team (BRT) to drive signal detection, analysis, risk management, and safety labelling.
- Represent Safety Science at the product level Medical Development Team, providing pharmacovigilance and clinical safety expertise.
- Lead Safety Science contribution for clinical development, including input on design, conduct, data analysis, and interpretation.
- Oversee clinical safety science interactions with partner companies, ensuring sharing of safety information.
- Lead development and implementation of signal management activities.
- Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile (TPP), and regulatory documents.
- Lead Safety Science input for post-marketing activities, including PASS-studies and additional risk minimisation measures.
- Support regulatory submissions, interactions, and product expansion activities.
- Respond to medical safety-related enquiries and support audits and inspections as required.
- Represent Global Pharmacovigilance in interactions with internal and external stakeholders, including Regulatory Authorities and Key Opinion Leaders.
Qualifications
- Higher level biomedical or scientific qualification (e.g., MD, PharmD or PhD)
- 8+ years of relevant clinical practice, clinical research experience and/or employment at a Drug Regulatory Agency or R&D in the Pharmaceutical Industry
- 5+ years involvement in assessment of signal evaluation and benefit/risk of medicines in a global pharmaceutical company or a Drug Regulatory Agency
- Experience leading cross-functional global product safety management teams
- In-depth knowledge of pharmacovigilance processes, practices, and regulations (e.g., GCP and GVP)
Desired
- Experience working with partner companies in global markets
- Experience presenting medical safety information at Health Authority meetings
Skills/Knowledge/Languages
- Fluency in written and spoken English
- Strong communication and team-leadership capabilities
- Sound judgment skills and ability to assess and handle risks
- Expertise in resolving or escalating issues as appropriate
Global Product Safety Science Lead 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 Science Lead in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Sobi or similar companies. A friendly chat can sometimes lead to opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching Sobi’s products and recent developments in pharmacovigilance. Show us you’re not just another candidate; demonstrate your passion for safety science and how you can contribute to our mission.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Global Product Safety Science Lead. We want to hear about your leadership in cross-functional teams and your expertise in risk management.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re genuinely interested in joining our team.
We think you need these skills to ace Global Product Safety Science Lead in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Global Product Safety Science Lead role. Highlight your relevant experience in pharmacovigilance and clinical safety, and don’t forget to showcase your leadership skills in cross-functional teams.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about safety science and how your background aligns with Sobi’s mission. Keep it concise but impactful, and make sure to address the key responsibilities mentioned in the job description.
Showcase Your Expertise: In your application, be sure to highlight your in-depth knowledge of GCP and GVP regulations. Mention any specific experiences where you’ve successfully managed safety science activities or led multidisciplinary teams, as this will resonate well with us.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of being noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Sobi - Swedish Orphan Biovitrum AB (publ)
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance processes and regulations like GCP and GVP. Being able to discuss these in detail will show that you’re not just familiar with the basics, but that you truly understand the complexities of safety science.
✨Showcase Your Leadership Skills
As a Global Product Safety Science Lead, you'll need to lead cross-functional teams. Prepare examples from your past experiences where you've successfully led teams or projects, especially in a global context. This will demonstrate your capability to manage diverse groups effectively.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific safety-related scenarios or challenges. Think through potential situations you might face in this role and how you would approach them. This shows your problem-solving skills and readiness for the role.
✨Engage with Your Interviewers
Don’t just answer questions; engage in a dialogue. Ask insightful questions about Sobi’s products and their safety strategies. This not only shows your interest but also gives you a chance to demonstrate your knowledge and enthusiasm for the role.
