Associate Director, Pharmacovigilance Scientist

Biogen • Remote, OR

403d

About The Position

The Associate Director, Pharmacovigilance Scientist is a key role within the Safety Surveillance and Aggregate Reports (SSA) team at Biogen. This position is responsible for managing the processes related to Aggregate Reports, including PSURs, DSURs, PADERs, and local reports. The Associate Director will serve as a subject matter expert on safety requirements for Aggregate Reports globally and will lead the production of these reports, ensuring compliance with pharmacovigilance regulations. The role also involves process improvement initiatives and collaboration with various stakeholders to maintain high-quality standards in report production.

Requirements

• Bachelor's Degree in biologic or natural science or an advanced degree (MSc, PhD, MPH, PharmD, etc.).
• Minimum 8-10 years of Pharmacovigilance experience, including experience in aggregate safety reports writing and responses to health authorities.

Nice To Haves

• Experience in safety signal management in both clinical trial settings and post-marketing.

Responsibilities

• 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 and company policies related to pharmacovigilance activities.
• Manage the Aggregate Reports Master Schedule and worldwide legislation overview.
• Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement.
• Oversee and mentor Pharmacovigilance Scientist staff.

Benefits

• Opportunities for learning and growth.
• Collaborative work environment.
• Commitment to diversity and inclusion.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree