Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage and author aggregate safety reports while collaborating with various teams.
- Company: Join Biogen, a pioneering biotechnology company dedicated to delivering life-changing medicines.
- Benefits: Enjoy a collaborative environment with opportunities for learning, growth, and impactful contributions.
- Why this job: Be part of a mission-driven team that values diversity and innovation in healthcare.
- Qualifications: Bachelor's degree in sciences; experience in pharmacovigilance and aggregate report writing required.
- Other info: Mentorship opportunities available for junior scientists in a fast-paced setting.
The predicted salary is between 36000 - 60000 £ per year.
Joining us as an Aggregate Report Senior Scientist, you will be a key member of the Safety Surveillance and Aggregate (SSA) Reports team within Global Safety and Regulatory Sciences (GSRS). In this role, you will be responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports. As a subject matter expert on global pharmacovigilance (PV) reporting requirements, you will collaborate with internal and external stakeholders, responding to safety queries, reviewing and supporting the authoring of medical and scientific safety information. You will work closely with vendors, vendor oversight teams, and quality management to ensure the highest standards in PV documentation. Additionally, you will contribute to process improvement initiatives and work cross-functionally to implement best practices in global safety compliance.
What You’ll Do
- Project manage and author aggregate safety reports (PSURs, DSURs, PADERs, local reports) alongside the PV Scientist Lead.
- Act as a subject matter expert on global safety regulations and company pharmacovigilance policies.
- Lead and coordinate responses to safety-related queries from regulatory authorities.
- Maintain and update the Aggregate Reports Master Schedule and oversee worldwide pharmacovigilance legislation requirements.
- Support and drive process improvements to enhance compliance, efficiency, and consistency in aggregate reporting.
- Collaborate with safety teams, clinical development, medical affairs, regulatory teams, and external vendors to ensure high-quality pharmacovigilance practices.
- Oversee and mentor junior Aggregate Reports Scientists, providing guidance on safety reporting best practices.
Who You Are
You are an experienced pharmacovigilance professional with strong expertise in aggregate safety report writing and safety signal management. You have a keen eye for detail and can interpret and present complex scientific and medical data clearly. You thrive in a collaborative environment, working cross-functionally to drive compliance and process improvements.
Qualifications Required Skills
- Bachelor's degree in biological or natural sciences (Advanced degree preferred – MSc, PhD, MPH, PharmD, etc.).
- Significant and proven pharmacovigilance experience, with expertise in authoring aggregate safety reports and signal management.
- Strong analytical skills with the ability to interpret and present medical and scientific data.
- Knowledge of global pharmacovigilance regulations and reporting requirements.
- Experience working with safety databases and common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects).
- Excellent organizational and teamwork skills, with the ability to work cross-functionally in a fast-paced environment.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Aggregate Report Senior Scientist employer: Biogen
Contact Detail:
Biogen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Aggregate Report Senior Scientist
✨Tip Number 1
Familiarise yourself with the latest global pharmacovigilance regulations and reporting requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the pharmacovigilance community, especially those who have experience in aggregate safety report writing. Engaging in discussions or attending relevant conferences can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to process improvements in previous roles. Highlighting your ability to enhance compliance and efficiency will resonate well with the hiring team.
✨Tip Number 4
Showcase your teamwork skills by preparing to discuss how you've collaborated with cross-functional teams in the past. Emphasising your ability to work effectively with various stakeholders will be crucial for this role.
We think you need these skills to ace Aggregate Report Senior Scientist
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Aggregate Report Senior Scientist position. Familiarise yourself with the key responsibilities and required skills, ensuring you can demonstrate your relevant experience in your application.
Tailor Your CV: Customise your CV to highlight your pharmacovigilance experience, particularly in aggregate safety report writing. Use specific examples that showcase your analytical skills and familiarity with global regulations to make your application stand out.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also reflects your passion for the role. Mention how your background aligns with Biogen's mission and values, and express your enthusiasm for contributing to their team.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application demonstrates attention to detail, which is crucial for the Aggregate Report Senior Scientist role.
How to prepare for a job interview at Biogen
✨Showcase Your Expertise
As an Aggregate Report Senior Scientist, it's crucial to demonstrate your deep understanding of pharmacovigilance and aggregate safety report writing. Be prepared to discuss specific experiences where you've successfully managed PSURs, DSURs, or PADERs, and how you navigated complex regulatory requirements.
✨Prepare for Technical Questions
Expect to face technical questions related to global pharmacovigilance regulations and reporting requirements. Brush up on the latest guidelines and be ready to explain how you've applied this knowledge in your previous roles, especially in relation to safety signal management.
✨Highlight Collaboration Skills
This role involves working closely with various teams and stakeholders. Share examples of how you've effectively collaborated cross-functionally in the past, particularly in driving compliance and process improvements. Emphasise your teamwork and communication skills.
✨Demonstrate Analytical Thinking
Given the importance of interpreting and presenting complex scientific data, be prepared to showcase your analytical skills. Discuss instances where you've successfully analysed data to inform decision-making or improve processes, and how this has contributed to high-quality pharmacovigilance practices.
