At a Glance
- Tasks: Manage Distribution Anchors and ensure compliance with regulatory requirements.
- Company: Global leader in drug and product safety operations.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with excellent career advancement opportunities.
- Why this job: Join a dynamic team and make a real impact in product safety.
- Qualifications: Degree or relevant experience in pharmacovigilance and regulatory reporting.
The predicted salary is between 40000 - 50000 £ per year.
Position Overview
Job Function: Product Safety
Job Sub‑Function: Drug & Product Safety Operations
Job Category: Professional
Hybrid work model
Locations:
- Bangalore, Karnataka, India
- Hyderabad, Andhra Pradesh, India
- High Wycombe, Buckinghamshire, United Kingdom (later to move to Maidenhead in 2026)
- Raritan, New Jersey, United States of America
- Titusville, New Jersey, United States of America
- Horsham, Pennsylvania, United States of America
Responsibilities:
- Set up and maintain Distribution Anchors (DAs) in the Global Safety System.
- Collaborate with internal and external partners to ensure DAs comply with regulatory reporting requirements.
- Write and update procedural documents and support continuous process improvement.
- Train and mentor other staff in DCM processes.
- Manage daily workload, ensuring Distribution rule‑related tasks are completed on time.
- Perform quality control activities on individual and team work.
- Conduct informal testing of new or modified DAs when required.
- Maintain close liaison with the Distribution Configuration Management team for workload management.
- Deputise for the Manager/Director as identified.
- Contribute to team meetings, identifying and resolving processing issues.
- Drive the creation and continuous improvement of consistent processes that meet internal and regulatory standards.
- Develop metrics to monitor key performance indicators across DCM areas.
- Assist the Manager with process implementation and issue management.
- Identify and resolve issues, preparing documentation and escalation options when necessary.
- Conduct impact assessments and bolus management activities related to DAs.
- Provide support and training to ensure compliance with collaboration with business partners and regulatory authorities.
- Assist with service level agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs) or Pharmacovigilance Agreements (PVAs).
- Liaise with other functional areas to resolve queries and issues.
- Act as a subject‑matter expert for regulatory reporting intelligence, quality monitoring activities, process/system improvement, compliance and quality metrics, controlled document creation/update and CAPA activities.
- Assist in maintaining knowledge of worldwide regulations related to ICSR case processing and reporting.
Minimum Qualifications:
- Degree and/or relevant work experience (advanced degree preferred).
- Understanding of US and EU electronic regulatory reporting requirements for ICSR.
- Experience in pharmacovigilance operations, including single case processing, database queries, and expedited reporting.
- Knowledge of regional and global safety regulations.
- Familiarity with technologies, systems and databases related to E2B electronic reporting.
- High reliability and compliance with legal and company guidelines.
- Excellent organizational and communication skills, including presentation abilities.
- Ability to produce high‑quality work under time‑critical and high‑pressure situations.
- Project management skills desirable.
Distribution Configuration Management Analyst in Aylesbury employer: Johnson & Johnson
As a Distribution Configuration Management Analyst, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. Our hybrid work model allows for flexibility, while our commitment to continuous improvement and regulatory compliance ensures that you will be part of a team that values innovation and excellence. With opportunities for training and mentorship, particularly in the vibrant locations of Bangalore and High Wycombe, you will find a rewarding career path that aligns with your professional aspirations.
StudySmarter Expert Advice🤫
We think this is how you could land Distribution Configuration Management Analyst in Aylesbury
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those working in pharmacovigilance or related fields. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their approach to drug safety and compliance. This will help you tailor your answers and show that you're genuinely interested in the role.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms. Focus on articulating your experience with regulatory reporting and process improvement, as these are key for the Distribution Configuration Management Analyst role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Distribution Configuration Management Analyst in Aylesbury
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Distribution Configuration Management Analyst role. Highlight relevant experience in pharmacovigilance operations and regulatory reporting, as this will show us you understand what we're looking for.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for the job. Share specific examples of how you've managed similar tasks or projects in the past, and don't forget to mention your understanding of US and EU regulations!
Showcase Your Skills:We want to see your organisational and communication skills shine through in your application. Use clear, concise language and structure your application so it's easy for us to read and understand your qualifications.
Apply Through Our Website:Don't forget to apply through our website! This ensures your application goes directly to us, and we can keep track of it easily. Plus, it shows you're keen on joining the StudySmarter team!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Stuff
Make sure you brush up on your knowledge of US and EU electronic regulatory reporting requirements for ICSR. Familiarise yourself with the Global Safety System and Distribution Anchors (DAs) as these will be key topics during your interview.
✨Showcase Your Experience
Be ready to discuss your previous experience in pharmacovigilance operations. Prepare specific examples of how you've handled single case processing, database queries, or expedited reporting. This will demonstrate your practical understanding of the role.
✨Communication is Key
Since this role involves collaboration with various partners, practice articulating your thoughts clearly. Highlight your organisational and presentation skills, and be prepared to discuss how you've effectively communicated complex information in past roles.
✨Problem-Solving Mindset
Think of examples where you've identified and resolved issues in a high-pressure environment. Be ready to explain your approach to quality control activities and how you’ve contributed to process improvements in your previous positions.
