Aggregate Report Senior Scientist
Aggregate Report Senior Scientist
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1 Vacancy
Job Description
About This Role
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 crossfunctionally to implement best practices in global safety compliance.
What Youll 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 safetyrelated 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 highquality 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 crossfunctionally to drive compliance and process improvements.
Qualifications :
Required Skills
- Bachelors 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 crossfunctionally in a fastpaced environment.
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
