At a Glance
- Tasks: Lead medical evaluations and ensure high-quality safety assessments in a global team.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Comprehensive benefits package, including health support and a commitment to inclusion.
- Other info: Join a diverse team focused on innovation and continuous improvement.
- Why this job: Make a real impact on patient safety and contribute to innovative therapies.
- Qualifications: Advanced medical degree and extensive experience in medical evaluation required.
The predicted salary is between 63000 - 77000 £ per year.
Join CSL as a Medical Evaluation Manager in the Case Management team within Global Safety and Pharmacovigilance (GSPV). You will oversee the timely delivery of high-quality medical evaluations by our vendor, train Medical Evaluators, provide guidance on complex cases and establish assessment frameworks. Through this work, you will help ensure the quality of our Individual Case Safety Reports (ICSRs).
Working across functions, you will help shape our global medical evaluation strategy, address challenges and drive process improvements.
Responsibilities:
- Oversee vendor activities to ensure high-quality, timely medical evaluation and processing of individual case safety reports.
- Apply medical and scientific judgment to assess safety information, including causality, expectedness, seriousness, and clinical relevance.
- Ensure medical evaluation activities comply with pharmacovigilance regulations, company standards, and applicable SOPs.
- Contribute to continuous process improvement, including review and enhancement of safety-relevant procedures.
- Collaborate with internal GSPV functions, cross-functional stakeholders, and the vendor to ensure consistent, high-quality safety assessments.
- Deliver onboarding training or knowledge-sharing activities to vendor Medical Evaluators.
- Identify potential challenges, risks, and roadblocks associated with the global medical evaluation strategy and work as a leader in developing solutions to address these, working cross-functionally with other departments.
- Support the monitoring of vendor performance, training, workload, and issue resolution through appropriate governance and oversight.
- Respond clearly and promptly to health authority queries related to case medical evaluation.
- Identify resources and tools necessary to facilitate risks and implement necessary risk management initiatives.
- Interface with key high-level internal and external stakeholders, contribute to and approve regulatory reports, submissions, and responses to queries.
Education:
Advanced Medical/Pharmacy Degree (e.g., MD or PharmD) or international equivalent.
Experience:
Seven (7) years of pharmaceutical/CRO industry experience, a significant proportion of which should be in a medical evaluation role, with a broad overview of all aspects of a PV system and specific experience with regulatory requirements. Experience in the medical assessment of complex biologic products, including vaccines and combination products, is desirable.
Competencies:
- Deep knowledge of PV concepts (e.g., CIOMS, listedness/expectedness, causality assessment, common AE grading and coding conventions, and ICSR management) and how safety decisions can impact other functions and patients.
- Experience and success in addressing and managing complex medical issues in pre-approval and post-approval environments.
- Conveying complex concepts through clear and concise messages.
- Demonstrating two-way communication by seeking and incorporating feedback to improve output and alignment.
- Providing appropriate direction, gaining commitment, developing, and empowering others.
Medical Evaluator - Global Case Management in Maidenhead employer: CSL Plasma
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises inclusion and belonging, making it a great place for professionals seeking to make a meaningful impact in the healthcare sector. With a strong focus on employee well-being, competitive benefits, and opportunities for growth within a global organisation, employees are empowered to thrive while contributing to vital health initiatives across the EMEA region. The hybrid work model further enhances work-life balance, allowing team members to collaborate effectively while enjoying flexibility in their roles.
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We think this is how you could land Medical Evaluator - Global Case Management in Maidenhead
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We think you need these skills to ace Medical Evaluator - Global Case Management in Maidenhead
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 CSL Plasma!
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 CSL Plasma that you're not just a fit for the job but also a safety-conscious candidate!
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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 CSL Plasma, 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 CSL Plasma
✨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 CSL Plasma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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.
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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.
