At a Glance
- Tasks: Lead global pharmacovigilance processes and ensure compliance with regulatory standards.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Work in a dynamic environment with a focus on cutting-edge technologies.
- Why this job: Join a mission-driven company and innovate in patient care and safety.
- Qualifications: 10+ years in Clinical Trials and Pharmacovigilance with leadership experience.
The predicted salary is between 80000 - 120000 £ per year.
You will oversee all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICRSs.
Key Responsibilities
- Oversight of Case Management Processes activities
- Oversight of Medical Evaluator role which completes medical review of the following ICRSs:
- All serious cases from all sources
- Non-serious cases from company-sponsored clinical study, if required
- Legal ICRSs (serious and non-serious)
- Reportable cases of combination products with device issue(s) / malfunction (serious and non-serious)
- Non-serious ICRSs are processed by Case Managers and reviewed for correct seriousness on an aggregate basis by Medical Evaluator
- Medical review includes:
- Review of seriousness, listedness and causality assessments
- Review of event terms and MedDRA coding
- Review of narrative for medical accuracy and consistency
- Assessment of the need for Quality Investigations
- Generation of medical follow up queries / Targeted Questionnaires
- Drive department-wide planning: resource, budget, and org. strategy
- Own case management dashboards and governance scorecards
- Prepare for internal and external inspections including coordination of creation of presentations
- Lead transformation initiatives (e.g., vendor transitions, digital tools)
- Monitor regulatory trends and represent PV case management in global initiatives
- Coordinate departmental leadership meetings and communication
- Pilot innovations (e.g., RPA, AI triage, tech integration)
- Align with Clinical, QA, Regulatory, and Safety Science functions
- Coordinate creation and update of SOPs
- Retain product and process knowledge
Skills and Education Required
- Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience.
- Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations.
- BS/BA, RN, Pharmacist, or similar.
Director, Medical Evaluation & Case Processing Oversight in Maidenhead employer: Meeveem Limited
CSL Behring is an exceptional employer, offering a dynamic work environment that prioritises innovation and patient care. With a strong commitment to employee growth, you will have access to extensive training and development opportunities, alongside a collaborative culture that values diversity and inclusion. Located in a global hub for biotherapeutics, you will be part of a team dedicated to saving lives while enjoying the benefits of working for a leading company in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Medical Evaluation & Case Processing Oversight in Maidenhead
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We think you need these skills to ace Director, Medical Evaluation & Case Processing Oversight 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 Meeveem Limited!
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How to prepare for a job interview at Meeveem Limited
✨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 Meeveem Limited 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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