Sr Manager Aggregate Reports Scientist
Sr Manager Aggregate Reports Scientist
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Salary Not Disclosed
1 Vacancy
Job Description
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 highquality standards. Collaborating with crossfunctional 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.
What Youll 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 crossSafety and crossfunctional 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 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 :
- Bachelors 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 crossfunctional 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.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
