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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 impact on patient 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 43200 - 72000 £ 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.
Sr. Manager, ICSR Quality in Maidenhead employer: CSL Behring
Contact Detail:
CSL Behring 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 your industry on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Knowing about CSL Behring’s mission and values will help you connect your experience to what they care about.
✨Tip Number 3
Practice your answers to common interview questions, but keep it natural. We want you to sound confident and authentic, not like a robot reciting a script!
✨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, we love seeing candidates who are proactive!
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 experience in pharmacovigilance and case management, and don’t forget to mention any relevant vendor management skills. We want to see how you fit into our world!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background aligns with our mission at CSL Behring. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Achievements: When detailing your experience, focus on specific achievements that demonstrate your expertise in quality oversight and compliance. Numbers and outcomes speak volumes, so if you've improved processes or led successful projects, let us know!
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, you’ll find all the info you need about our company culture and values there!
How to prepare for a job interview at CSL Behring
✨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.
✨Showcase Your Vendor Management Skills
Prepare examples of how you've successfully managed relationships with third-party vendors in the past. Highlight your experience in overseeing operational activities and resolving issues, as this role heavily involves vendor oversight. Be ready to discuss specific challenges you faced and how you overcame them.
✨Demonstrate Your Quality Assurance Knowledge
Familiarise yourself with quality assurance processes related to pharmacovigilance. Be prepared to discuss how you would ensure compliance and consistency in case processing. Mention any relevant audits or inspections you've been involved in, and how you contributed to corrective actions.
✨Emphasise Your Team Leadership Experience
As a Senior Manager, you'll need to lead and inspire your team. Share your leadership style and how you've successfully trained and developed team members in previous roles. Discuss how you foster a culture of inclusion and belonging, aligning with CSL's values.