Sr. Manager, Aggregate Reports Scientist ID-11564
About This Role
As a Senior Manager, Aggregate Report Scientist, you will be an integral part of the Safety Surveillance and Aggregate (SSA) Reports team. In this pivotal role, you will oversee the pharmacovigilance processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports, for a designated product or group of products. Your expertise will contribute significantly to managing signal activities, regulatory requests, literature reviews, and clinical trial safety undertakings. The value you bring to the team will be reflected in your role as a subject matter expert, offering guidance on safety requirements globally and ensuring high-quality standards. Collaborating with cross-functional groups, you will work on initiatives for process improvement, upholding compliance with global PV regulations. Your position will not only enhance the efficiency and consistency of our safety practices but also serve as a cornerstone in the development of our product safety profiles within the overarching business structure.
Virtual Assistant, $45/hr, Remote, No Experience, Night Job
Entry-Level Remote Data Entry, $50/hr, Evening Job
Customer Support, No Degree, $40/hr, Remote, Weekend Job
Remote Phone Job, $42/hr, Part-Time, College Student Friendly
Virtual Assistant, $40/hr, Remote, No Degree, Night Job
Part-Time Data Entry, $45/hr, Remote, College Student Friendly
Remote Moderator, No Degree, $50/hr, Evening, Weekend Job
Remote Customer Support, $42/hr, Night Job, No Experience
Live Chat Support, $40/hr, Remote, Entry Level, Part-Time
Virtual Assistant, Remote, $42/hr, Weekend, No Experience
Remote Data Entry, $45/hr, No Degree, Night Shift
Part-Time Customer Support, $40/hr, Remote, College Student
Remote Live Chat, $50/hr, Part-Time, Evening/Night Job
Entry Level Phone Job, $42/hr, Remote, No Degree Required
Weekend Data Entry, $45/hr, Remote, No Experience
Remote Virtual Assistant, $40/hr, Evening, Part-Time Job
Remote Moderator, $42/hr, Part-Time, Weekend, No Degree
Data Entry, $45/hr, Remote, Night Shift, College Student Job
Phone Support, Remote, $50/hr, No Experience, Part-Time
Virtual Assistant, No Experience, $42/hr, Remote, Weekend
Remote Customer Support, $45/hr, Part-Time, College Student
Data Entry, Remote, $40/hr, Night Shift, No Degree
Evening Virtual Assistant, Remote, $45/hr, No Experience
Weekend Customer Support, $42/hr, Remote, College Student
Remote Data Entry, $50/hr, No Experience, Evening/Night Job
Remote Live Chat, $40/hr, Part-Time, No Degree Required
Virtual Assistant, $42/hr, Remote, Weekend, Entry Level
Remote Phone Support, $45/hr, Evening, No Experience Required
Data Entry, No Experience, $50/hr, Remote, College Student
Remote Moderator, $40/hr, Weekend, No Degree, Part-Time
Live Chat Support, Remote, $42/hr, Night Shift, College Student
Phone Job, $50/hr, Remote, No Degree, Part-Time, Weekend
Data Entry, $45/hr, Remote, Evening, No Experience Required
Virtual Assistant, No Experience, $42/hr, Remote, Part-Time
Remote Customer Support, $50/hr, Night Shift, No Degree
Remote Data Entry, $40/hr, College Student Friendly, Part-Time
Live Chat Support, $42/hr, Weekend, Remote, No Degree
Virtual Assistant, Remote, $45/hr, Evening, No Experience
Remote Phone Job, $50/hr, College Student, Night Shift
Remote Moderator, $42/hr, Weekend, No Experience Required
Data Entry, No Degree, $45/hr, Part-Time, Remote Job
Customer Support, $50/hr, Remote, Evening/Night Job, No Degree
Virtual Assistant, $42/hr, Remote, Weekend, No Degree
Remote Live Chat, $45/hr, College Student, No Experience
Remote Data Entry, $40/hr, Part-Time, No Degree Required
Phone Support, $50/hr, Weekend, Remote, No Experience
Virtual Assistant, $42/hr, Evening, Remote, No Degree
Remote Customer Support, $45/hr, No Experience, Part-Time
Data Entry, $50/hr, Night Job, No Degree, Remote
Remote Moderator, $40/hr, College Student Friendly, Part-Time
Virtual Assistant, Remote, $42/hr, Weekend, No Experience
Remote Phone Job, $45/hr, Part-Time, No Degree Required
Customer Support, $50/hr, Night Job, Remote, No Experience
Data Entry, Remote, $42/hr, Evening Job, No Degree
Live Chat Support, $45/hr, Weekend, Remote, College Student
Virtual Assistant, Remote, $50/hr, Part-Time, Night Shift
Data Entry, $40/hr, No Experience, Remote, Weekend Job
Remote Phone Job, $45/hr, No Degree, College Student Friendly
Customer Support, $42/hr, Remote, Evening, No Experience
Virtual Assistant, $50/hr, Weekend, No Degree, Remote
Remote Data Entry, $40/hr, Part-Time, College Student Job
Phone Support, Remote, $42/hr, Evening/Night Shift
Virtual Assistant, No Degree, $45/hr, Remote, Part-Time
Live Chat Support, $50/hr, Remote, No Experience Required
Remote Moderator, $42/hr, College Student, Weekend Job
Data Entry, $45/hr, Remote, Night Job, No Degree
Virtual Assistant, $50/hr, Remote, Part-Time, Evening Job
Remote Customer Support, $42/hr, Weekend, No Experience
Phone Job, $45/hr, Remote, Night Shift, No Degree
Remote Live Chat, $50/hr, College Student, No Experience
Data Entry, $40/hr, Part-Time, Remote, Weekend Job
Virtual Assistant, $42/hr, Remote, No Experience, Evening
Remote Phone Support, $45/hr, Night Job, College Student
Remote Moderator, $50/hr, No Degree, Weekend, Part-Time
Virtual Assistant, $40/hr, Remote, Night Shift, No Experience
Customer Support, $42/hr, Remote, Part-Time, No Degree
Remote Data Entry, $45/hr, Weekend Job, College Student
Phone Support, Remote, $50/hr, No Experience, Night Shift
Virtual Assistant, $42/hr, Evening, Remote, College Student
Live Chat Support, $45/hr, Part-Time, Remote, No Degree
Data Entry, $50/hr, Remote, Evening Job, College Student
Virtual Assistant, $40/hr, Weekend, Remote, No Experience
Remote Phone Job, $42/hr, Night Shift, College Student Friendly
Remote Customer Support, $45/hr, No Degree, Evening Job
Virtual Assistant, $50/hr, Part-Time, Remote, Weekend Job
Data Entry, $40/hr, Evening Job, No Experience, Remote
Remote Live Chat, $42/hr, Weekend, No Degree, Part-Time
Virtual Assistant, $45/hr, No Experience, Remote, Night Job
Phone Job, $50/hr, Remote, Part-Time, College Student
Remote Data Entry, $42/hr, Evening/Night Job, No Experience
Remote Moderator, $45/hr, No Degree, Weekend Job, Part-Time
Live Chat Support, $50/hr, Remote, Night Shift, No Degree
Virtual Assistant, $40/hr, Weekend, College Student, Remote
Remote Phone Job, $42/hr, Part-Time, No Experience Required
Remote Data Entry, $45/hr, No Degree, Weekend, Night Job
Virtual Assistant, $50/hr, Evening, Remote, College Student
Customer Support, $42/hr, Weekend Job, Remote, No Degree
Phone Support, $45/hr, Remote, No Experience, Evening Job
Data Entry, $50/hr, Night Shift, No Degree, Remote Job
What You’ll Do
- Manage the project planning and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, and local reports, in close collaboration with the PV scientist Lead.
- Serve as a subject matter expert on global safety requirements, company policies, and procedures related to pharmacovigilance activities.
- Implement and oversee process improvement initiatives, contributing to the maintenance of compliant and efficient operations.
- Maintain the Aggregate Reports Master Schedule, ensuring compliance with worldwide legislation and facilitating stakeholder reviews.
- Coordinate with the PV Scientist lead to author comprehensive responses to safety inquiries from regulatory authorities.
- Spearhead initiatives aimed at enhancing the consistency of aggregate reporting, clinical trial safety oversight, signal management, and ad hoc safety question responses.
- Independently and collaboratively lead substantive projects, such as the authoring of aggregate data reports and regulatory requests, while providing mentorship to less experienced PV Scientist staff.
- Represent the team in cross-Safety and cross-functional forums, effectively communicating processes and project outcomes.
- Manage substantive projects like signaling and authoring of aggregate data reports, ensuring successful completion by direct reports.
- Utilize clinical judgment to interpret case information and guide staff in clinical evaluation.
Who You Are
You are a Subject Matter Expert in authoring Aggregate Reports and are able to author reports concisely under a tight deadline. Additionally, you are a visionary with a keen eye for detail and a passion for scientific rigor. With your advanced understanding of medical concepts, you are adept at presenting complex data with clarity and precision. As a collaborative team player, you engage effectively within diverse teams, including Safety, Clinical Development, and Regulatory Affairs, and you thrive when working with external partners.
Qualifications
- Bachelor’s Degree in biologic or natural science or advanced degree (MSc, PhD, MPH, PharmD, etc.)
- Minimum 8 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management.
- Expertise in management and authoring of aggregate data reports.
- Proficiency in analyzing, interpreting, and presenting scientific and medical data both verbally and in writing.
- Demonstrated ability to work collaboratively in a team environment and with external partners.
- Experience in leading and conducting significant projects independently or in a team setting.
- Strong communication skills in cross-functional forums.
- Proven capability to manage and oversee substantial projects, including signaling and authoring of data reports.
- Strong organizational skills with the ability to independently prioritize and manage tasks.
- Basic knowledge of data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and safety database systems.
Position is Remote based in the U.S.
Additional Information
The base compensation range for this role is $138,000 - $200,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
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. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
