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For Companies At a Glance
- Tasks: Oversee global pharmacovigilance vendors and ensure quality in case processing.
- Company: CSL Behring, a leader in biotherapeutics dedicated to saving lives.
- Benefits: Hybrid work model, competitive salary, and comprehensive health benefits.
- Why this job: Join a mission-driven company making a real difference in patients' lives.
- Qualifications: 8+ years in clinical trials and pharmacovigilance; strong regulatory knowledge required.
- Other info: Inclusive culture that values diversity and fosters innovation.
The predicted salary is between 36000 - 60000 £ per year.
The Opportunity
Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and you will be responsible for the oversight and control of the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products. This is a hybrid role, which offers a combination of an onsite and remote work schedule.
The Role
- Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to governance, financials, contracts, quality and training, and resourcing.
- Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
- Oversee case management vendor(s) to manage and resolve emerging issues.
- Develop and/or maintain/update existing documents for relevant vendor responsibilities.
- Contributes to ICSR quality strategy.
- Responsible for Global ICSR Reconciliation activities.
- Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.
Your Skills & Abilities
- BS/BA, RN, Pharmacist, or equivalent.
- Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
- Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
- Experience working with third parties (e.g., contract service providers) and relationship management.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Sr. Manager, ICSR Quality in Maidenhead employer: CSL Plasma
Contact Detail:
CSL Plasma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Manager, ICSR Quality in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those connected to CSL Behring. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for the interview by diving deep into ICSR quality management. Brush up on your knowledge of global pharmacovigilance regulations and be ready to discuss how you can contribute to CSL's mission.
✨Tip Number 3
Showcase your experience with third-party vendors. Be ready to share specific examples of how you've managed relationships and resolved issues in past roles—this will highlight your fit for the Senior Manager position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the CSL team.
We think you need these skills to ace Sr. Manager, ICSR Quality in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Senior Manager, ICSR Quality. Highlight your relevant experience in pharmacovigilance and case management, and don’t forget to mention any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this hybrid role. Mention your experience with vendor management and how you can contribute to CSL Behring’s mission of saving lives.
Showcase Your Skills: In your application, be sure to showcase your skills in global pharmacovigilance databases and your understanding of regulatory rules. This will demonstrate your capability to oversee quality and compliance effectively.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets the attention it deserves, and we can’t wait to see what you bring to the table!
How to prepare for a job interview at CSL Plasma
✨Know Your ICSR Inside Out
Make sure you have a solid understanding of Individual Case Safety Reports (ICSRs) and their significance in pharmacovigilance. Brush up on the latest regulations and guidelines, as well as any recent developments in the field. This will show your expertise and commitment to quality.
✨Vendor Management Experience is Key
Be prepared to discuss your experience with managing third-party vendors. Think of specific examples where you've successfully overseen vendor relationships, resolved issues, or improved processes. This will demonstrate your ability to handle the operational management aspect of the role.
✨Showcase Your Quality Assurance Skills
Highlight your experience in quality assurance and compliance within pharmacovigilance. Be ready to talk about how you've contributed to quality strategies or managed audits and inspections in the past. This will align perfectly with the responsibilities of overseeing case management vendors.
✨Prepare Questions About Their Culture
Since CSL Behring values inclusion and belonging, come prepared with thoughtful questions about their company culture. This shows that you’re not just interested in the role but also in how you can contribute to their mission and work environment.