Sr Associate II, Drug Safety

The Sr Associate II, Drug Safety is accountable for the end-to-end operational management of Adverse Events of Special Interest (AESIs) across the product lifecycle, including both Clinical Trial and Post-Marketing settings. This role serves as a central coordination hub for internal stakeholders, ensuring timely identification, escalation, and communication of AESIs across the Safety Organization. The Sr Associate II, Drug Safety is accountable for overseeing day-to-day AESI case handling activities outsourced to a vendor, ensuring that case identification, processing, and follow-up are conducted in accordance with Biogen procedures. This includes ongoing vendor oversight, issue resolution, and performance monitoring.

Principle responsibilities

• Ensures all AE case processing, in both the Post-Marketing and Clinical Trial settings, is conducted in compliance with regulatory requirements, corporate and departmental procedure and data handling conventions by maintaining and executing oversight plans for vendors (CROs) with case processing responsibilities.
• Monitors Biogen Global Safety Database (GSD) and identifies and communicates to appropriate internal stakeholders on events of interest in both Post-Marketing and Clinical Trial settings
• Monitors the compliance and health of the case processing workflow continuously through the use of various monitoring reports
• Monitors the quality of outsourced AESI case processing activities, ensuring high-quality, clinically appropriate queries are developed and issued for AESIs.
• Supports PML adjudication meetings and is accountable for the presentation of the AESI clinical data to the adjudication committee and documentation and dissemination of key decisions to stakeholders
• Supports team leadership in execution of AESI -related activities, including contribution to regulatory deliverables for PML, and internal analyses (e.g. FDA AEMS).

• Bachelor's degree in nursing, pharmacy, or other health related profession
• 2+ years experience in a Drug Safety environment
• Solid understanding of worldwide Post-Marketing and Clinical Trial Adverse Event Regulations including GCP, CIOMS, EMA GVP
• Strong ability to understand, evaluate, and succinctly summarize technical, scientific and medical information
• Ability to interpret regulations and apply the interpretation to departmental SOPs and guidelines
• Strong collaborator with effective communication skills in team and matrix environments
• Highly organized, adaptable, and able to manage multiple priorities in a fast-paced setting
• Critical thinker with strong problem-solving abilities
• Exercises sound judgment in workflow assessment and decision-making
• Proficient in computer systems and quick to learn new tools and technologies

• 3+ years experience in a clinical setting

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation