Job Description
About This Role
This role reports into the Head of Aggregate Reports and will be part of the Safety Surveillance and Aggregate Reports (SSA) team. The Associate Director, Pharmacovigilance Scientist is responsible for managing the processes for all Aggregate Reports such as PSURs, DSURs, PADERs and local reports.
The Associate Director will be the subject matter expert on Aggregate Reports safety requirements worldwide and lead independently all aspects of the production of an Aggregate Safety Report, including responses to safety questions from health authorities.
This role leads independently initiatives for process improvement and efficiencies, and collaborates with stakeholders to develop, implement and maintain processes that are compliant with global PV regulations for Aggregate Safety Reports.
There will be close collaboration with vendors, SSA vendor oversight team, and with the SSA Quality Management team to ensure high quality standards of the Aggregate Safety Reports.
What You'll Do
- Lead independently and collaboratively all aspects of substantive projects including authoring aggregate safety reports and responses to regulatory agency requests.
- Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as in-depth Aggregate Reports knowledge. Serve as example for behaviors that lead to high quality outputs.
- Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview.
- Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement, implements and maintains processes. Manage corrective actions when non-compliances are identified.
- Oversee and mentor PV Scientist staff.
Who You Are
You are curious and have an analytical mind. You are enthusiastic and thrive working in a highly collaborative team. You enjoy working with medical scientific data sets to provide well written conclusions. You do not shy away from providing suggestions for process improvements. You enjoy guiding stakeholders in current processes or legislative requirements.
Qualifications
- Bachelor's Degree in biologic or natural science OR Advanced degree (MSc, PhD, MPH, PharmD, etc.)
- Minimum 8-10 years Pharmacovigilance experience, including experience in aggregate safety reports writing, responses to health authorities, and safety signal management in both clinical trial setting and post-marketing.
Additional Information
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.