At a Glance
- Tasks: Manage pharmacovigilance agreements and ensure patient safety in innovative biopharmaceutical collaborations.
- Company: Join Sobi, a global leader in biopharmaceuticals focused on rare diseases.
- Benefits: Competitive salary, professional development, and the chance to make a real impact.
- Other info: Dynamic role with opportunities for growth in a collaborative international environment.
- Why this job: Be part of a team that transforms lives through innovative treatments and strategic partnerships.
- Qualifications: Bachelor's in Life Sciences and 3+ years in pharmacovigilance or regulatory affairs.
The predicted salary is between 60000 - 80000 £ per year.
Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. We are seeking a dynamic and experienced Senior Pharmacovigilance Agreements Manager to join our team. As a key member of our Global Pharmacovigilance Agreements (PVA) team, you will play a crucial role in managing strategic collaborations and alliances to ensure the highest standards of patient safety and regulatory compliance.
Key Responsibilities:
- Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables.
- Contribute to strategy setting in collaboration with line management as required, ensuring compliant and efficient solutions for all parties.
- Collaborate with global functions to provide expert advice and support on commercial agreements, named patient use supplies, and other managed access programs, ensuring optimal and compliant pharmacovigilance obligations are embedded.
- Work closely with internal Patient Safety functions and cross-functional Sobi departments to ensure full alignment with Global Pharmacovigilance (GPV) agreements.
- Oversee and manage pharmacovigilance collaborations and alliances with external business partners, including co-marketing, co-development, distributor partners, and healthcare organizations.
- Lead the negotiation and establishment of pharmacovigilance agreements, clearly defining roles, responsibilities, and conditions to enable seamless collaboration.
- Partner efficiently with the Sobi Global Pharmacovigilance group and other key stakeholders to ensure PVAs are effectively implemented, maintained, and monitored.
- Provide subject matter expertise on current and evolving pharmacovigilance regulations and guidelines, both internally and externally.
- Support pharmacovigilance audits and inspections related to collaborations, including contribution to corrective and preventive action (CAPA) plans.
- Train and educate internal teams on pharmacovigilance standards, procedures, and collaboration requirements.
- Continuously identify opportunities for process improvement, efficiency gains, and risk mitigation across pharmacovigilance collaborations.
Qualifications:
- Bachelor's degree preferably in Life Sciences or relevant scientific discipline.
- Minimum of 3 years of experience in the pharmaceutical industry, with solid experience in pharmacovigilance, regulatory affairs and or quality assurance, with a focus on safety alliance or collaboration management.
- At least 2-3 years of specific experience in managing patient safety alliances or partnership.
- Strong understanding of global and local pharmacovigilance regulations and guidelines.
- Excellent negotiation, communication, and problem-solving skills.
- Able to drive towards solutions and reach common grounds.
- Proven ability to work effectively in cross-functional and international teams.
- Strong organizational skills with the ability to manage multiple projects, motivated and driven - able to take ownership of a complex agreement process and drive it through to finalisation in agreed timeframes.
- Proficiency in written and spoken English; knowledge of other languages is advantageous.
If you are a motivated professional with a passion for patient safety, collaboration, and regulatory compliance, we invite you to join our Global PV team, develop and maintain our PV system to deliver our portfolio of product for rare disease to patients across the globe and make a significant impact in our organisation. We look forward to your contribution to the future of patient safety through strategic alliances and partnerships.
Pharmacovigilance Licensing Manager in Cambridge employer: Sobi
Sobi is an exceptional employer that prioritises innovation and collaboration in the biopharmaceutical sector, particularly in the realm of rare diseases. With a vibrant work culture based in Stockholm, employees benefit from a supportive environment that fosters professional growth and development, alongside competitive remuneration and comprehensive benefits. Joining Sobi means being part of a dedicated team that values patient safety and regulatory excellence, offering unique opportunities to make a meaningful impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land Pharmacovigilance Licensing Manager in Cambridge
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We think you need these skills to ace Pharmacovigilance Licensing Manager in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Sobi!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Sobi that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Sobi!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Sobi, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Sobi
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Sobi that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Sobi’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
